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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02931539




Registration number
NCT02931539
Ethics application status
Date submitted
29/09/2016
Date registered
13/10/2016

Titles & IDs
Public title
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Scientific title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Secondary ID [1] 0 0
2015-004725-13
Secondary ID [2] 0 0
SHP620-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus (CMV) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Maribavir
Treatment: Drugs - Ganciclovir
Treatment: Drugs - Valganciclovir
Treatment: Drugs - Foscarnet
Treatment: Drugs - Cidofovir

Experimental: Maribavir Treatment - Participants will receive 400 milligrams (mg) (2x200 mg tablets) maribavir twice daily orally (doses separated by a minimum of 8 hours) for 8 weeks.

Active comparator: Investigator-Assigned Treatment - Participants will receive anti-CMV agent best suited to treat the respective participant as per the investigator's prescribed dosing regimen for 8 weeks. Agents of choice include: ganciclovir, valganciclovir, foscarnet, or cidofovir.


Treatment: Drugs: Maribavir
Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.

Treatment: Drugs: Ganciclovir
Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Treatment: Drugs: Valganciclovir
Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Treatment: Drugs: Foscarnet
Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Treatment: Drugs: Cidofovir
Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16
Timepoint [1] 0 0
Up to Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment
Timepoint [2] 0 0
At Week 8 through Weeks 12, 16 and 20
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20
Timepoint [3] 0 0
At Week 8 through Weeks 12, 16 and 20
Secondary outcome [4] 0 0
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Timepoint [4] 0 0
At Week 8 through Weeks 12 and 20
Secondary outcome [5] 0 0
Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Timepoint [5] 0 0
At Week 8
Secondary outcome [6] 0 0
Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Timepoint [6] 0 0
End of Week 8 up to Week 20 (12 weeks follow-up period)
Secondary outcome [7] 0 0
Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Timepoint [7] 0 0
Baseline up to Week 20
Secondary outcome [8] 0 0
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment
Timepoint [8] 0 0
Baseline up to Week 8
Secondary outcome [9] 0 0
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period
Timepoint [9] 0 0
End of Week 8 up to Week 20 (12 weeks follow-up period)
Secondary outcome [10] 0 0
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study
Timepoint [10] 0 0
Baseline up to Week 20
Secondary outcome [11] 0 0
Percentage of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment
Timepoint [11] 0 0
Baseline up to termination of study treatment (up to Week 8)
Secondary outcome [12] 0 0
Percentage of Participants With Recurrence of CMV Viremia While Off Study-assigned Treatment During Follow-up Period
Timepoint [12] 0 0
Termination of study treatment (Week 8) up to the End of the Study (Week 20)
Secondary outcome [13] 0 0
Number of Participants Who Had Maribavir CMV Resistance at Baseline
Timepoint [13] 0 0
At Baseline
Secondary outcome [14] 0 0
Number of Participants Who Had Post-baseline Resistance to Maribavir
Timepoint [14] 0 0
After first dose of study drug up to Week 20
Secondary outcome [15] 0 0
Number of Participants With All-cause Mortality by the End of the Study
Timepoint [15] 0 0
From enrollment up to end of study (approximately 44 months)
Secondary outcome [16] 0 0
Time to All Cause Mortality
Timepoint [16] 0 0
From enrollment to last serious adverse event (SAE) follow-up (approximately Week 28)
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at End of Week 8 After Starting Maribavir Rescue Treatment
Timepoint [17] 0 0
From start of maribavir rescue treatment through 8 weeks
Secondary outcome [18] 0 0
Percentage of Participants Receiving Maribavir Rescue Treatment Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16
Timepoint [18] 0 0
Up to Week 16
Secondary outcome [19] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period
Timepoint [19] 0 0
Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)
Secondary outcome [20] 0 0
Predose Concentration (Cmin) of Maribavir
Timepoint [20] 0 0
Predose at Week 1, 4 and 8
Secondary outcome [21] 0 0
Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Participants
Timepoint [21] 0 0
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose, Week 4: Pre-morning dose, and Week 8: Pre-morning dose and 2-4 hour post morning dose
Secondary outcome [22] 0 0
Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Participants
Timepoint [22] 0 0
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Secondary outcome [23] 0 0
Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants
Timepoint [23] 0 0
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Secondary outcome [24] 0 0
Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants
Timepoint [24] 0 0
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Secondary outcome [25] 0 0
Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants
Timepoint [25] 0 0
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose

Eligibility
Key inclusion criteria
1. The participant must be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant before completing any study-related procedures.
2. The participant must be a recipient of hematopoietic stem cell or solid organ transplant.
3. The participant must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) 2730 international units per milliliter (IU/mL) in whole blood or >= 910 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.
4. The participant must have a current CMV infection that is refractory to the most recently administered of the four anti-CMV treatment agents. Refractory is defined as documented failure to achieve greater than (>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir.

a. Participants with documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, foscarnet, and/or cidofovir must also meet the definition of refractory CMV infection.
5. The Investigator must be willing to treat the participant with at least one of the available anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, or cidofovir). Note: Combination therapy with foscarnet and cidofovir is not permitted in the investigator-assigned anti-CMV treatment (IAT) arm due to the potential for serious nephrotoxicity.
6. The participant must be >= 12 years of age at the time of consent.
7. The participant must weigh >= 35 kilogram (kg).
8. The participant must have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):

1. Absolute neutrophil count (ANC) >= 1000/ millimeter cube (mm^3) (1.0 x 10^9/liter [L])
2. Platelet count >= 25,000/mm^3 [25 x 10^9/L],
3. Hemoglobin >= 8 grams per deciliter (g/dL).
4. Estimated glomerular filtration rate (eGFR) > 30 (milliliters per minute (mL/min) /1.73 square meter (m^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula for participants >= 18 years of age or Schwartz formula for participants less than (<) 18 years of age.
9. The participant must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
10. The participant must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube.
11. The participant must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
12. The participant must be willing to provide necessary samples (example [e.g,] biopsy) for the diagnosis of tissue invasive CMV disease at baseline as determined by the Investigator.
13. The participant must have a life expectancy of >= 8 weeks.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to prior anti-CMV treatment, to the best knowledge of the Investigator.
2. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus (HSV) coinfection requiring use of any of these agents after the randomization) or would need a coadministration with maribavir for CMV infection. NOTE: A participant who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or foscarnet) for the study treatment (if randomized to the investigator assigned anti-CMV treatment arm), must discontinue their use before the first dose of study drug. If participant is currently being treated with cidofovir and is assigned another anti-CMV therapy by the investigator, the participant must discontinue its use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment.
3. Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. NOTE: Participants receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use at least 3 days prior to the first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
4. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral/enteral medication.
5. Have known hypersensitivity to the active substance or to an excipient for a study treatment.
6. Have tissue invasive CMV disease with central nervous system involvement including the retina (example, CMV retinitis).
7. Have serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome), by local or central lab. Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT > 5 times ULN at screening.
8. Have known positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
10. Be female and pregnant or breast feeding.
11. Have previously received maribavir.
12. Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or investigational CMV vaccine at any time.
13. Have received any unapproved agent or device within 30 days before initiation of study treatment.
14. Have active malignancy with the exception of nonmelanoma skin cancer. Participants who have had a hematopoietic stem cell transplant (HSCT) and who experience relapse or progression of the malignancy as per investigator's opinion are not to be enrolled.
15. Be undergoing treatment for acute or chronic hepatitis C.
16. Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2020
Sample size
Target
Accrual to date
Final
352
Recruitment in Australia
Recruitment state(s)
NSW,VIC,Washingto
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Washington
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams Brabant
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Belgium
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West-Vlaanderen
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Belgium
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Bruxelles
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Zagreb
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Denmark
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Capital
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France
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Finistère
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France
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Haute-Garonne
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France
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Hauts-de-Seine
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France
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Ille-et-Vilaine
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France
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Indre-et-Loire
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France
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Loire-Atlantique
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France
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Rhône
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France
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Val-de-Marne
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France
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AMIENS Cedex 1
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France
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Amiens
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France
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Clermont-Ferrand
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France
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Grenoble
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Lille Cedex
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France
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Limoges Cedex
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France
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Lyon
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France
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Paris
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France
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Poitiers
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France
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Saint-Priest en Jarez
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France
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STRASBOURG Cedex
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France
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Strasbourg
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Erlangen
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Germany
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Heidelberg
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Germany
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München
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Germany
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Tübingen
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Italy
State/province [67] 0 0
Lombardia
Country [68] 0 0
Italy
State/province [68] 0 0
Marche
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Italy
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Parma
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Italy
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Pisa
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Italy
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Roma
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Italy
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Udine
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Barakaldo
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Salamanca
Country [79] 0 0
Spain
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Valencia
Country [80] 0 0
Switzerland
State/province [80] 0 0
Vaud (fr)
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Birmingham
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Glasgow City
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London, City Of
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Manchester
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Yorkshire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Liverpool
Country [87] 0 0
United Kingdom
State/province [87] 0 0
London
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Shire
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02931539