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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03117569




Registration number
NCT03117569
Ethics application status
Date submitted
7/04/2017
Date registered
18/04/2017

Titles & IDs
Public title
Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
Scientific title
A Phase IIIb, Open-label, Multicentre, International Randomised Controlled Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir (300mg)/Pibrentasvir (120mg) in Chronic HCV Treatment naïve Patients Without Cirrhosis
Secondary ID [1] 0 0
VHCRP1701
Universal Trial Number (UTN)
Trial acronym
SMART-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - glecaprevir (300mg)/pibrentasvir (120mg)

Other: Standard monitoring schedule - Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).

Experimental: Simplified monitoring schedule - Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.


Treatment: Drugs: glecaprevir (300mg)/pibrentasvir (120mg)
glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Undetectable HCV RNA (ITT Population)
Timepoint [1] 0 0
12 weeks post end of treatment (SVR12)
Secondary outcome [1] 0 0
Undetectable HCV RNA (mITT Population)
Timepoint [1] 0 0
12 weeks post end of treatment (SVR12)
Secondary outcome [2] 0 0
Treatment and Study Visits Adherence
Timepoint [2] 0 0
12 weeks post end of treatment (SVR12)
Secondary outcome [3] 0 0
Health-related Quality of Life
Timepoint [3] 0 0
Screening and 12 weeks post end of treatment (SVR12)
Secondary outcome [4] 0 0
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
Timepoint [4] 0 0
Baseline and 12 weeks post-treatment
Secondary outcome [5] 0 0
Patient Treatment Satisfaction
Timepoint [5] 0 0
12 weeks post end of treatment (SVR12)

Eligibility
Key inclusion criteria
1. Have voluntarily signed the informed consent form.
2. 18 years of age or older.
3. Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
4. HCV RNA plasma = 10,000 IU/ml at screening.
5. HCV genotype 1-6.
6. HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
7. Stage F0-3, based on: hepatic elastography <12.5 kPa on Fibroscan® or APRI <1.0.
8. If co-infection with HIV is documented, the subject must meet the following criteria:

* ART naïve with CD4 T cell count >500 cells/mm3; OR
* On a stable ART regimen (containing only permissible ART - see protocol section 3.2) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
9. Negative pregnancy test at screening and baseline (females of childbearing potential only).
10. All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of any of the following:

1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
2. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
3. Solid organ transplant.
4. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
2. Any of the following lab parameters at screening:

1. ALT > 10 x ULN
2. AST > 10 x ULN
3. Direct bilirubin > ULN
4. Platelets < 90,000/µL (cells/mm3) if Fibroscan® <12.5 kPa OR < 150,000/µL (cells/mm3) if Fibroscan® is unavailable and patient is included with APRI <1
5. Creatinine clearance (CLcr) < 50 mL/min
6. Haemoglobin < 12g/dL for males; <11g/dL for females
7. Albumin < LLN
8. INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
3. Pregnant or breastfeeding female.
4. HBV infection (HBsAg positive).
5. Use of prohibited concomitant medications as described in protocol section 5.2.
6. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).
7. Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) =6 months prior to the first dose of study drug.
8. Any investigational drug =6 weeks prior to the first dose of study drug.
9. Ongoing severe psychiatric disease as judged by the treating physician.
10. Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, propoxyphene, or alcohol, with the exception of a positive result (including methadone) associated with documented short-term use or chronic stable use of a prescribed medication in that class.
11. Injecting drug use within the previous six months.
12. Inability or unwillingness to provide informed consent or abide by the requirements of the study.

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
21/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2018
Sample size
Target
Accrual to date
Final
380
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
France
State/province [8] 0 0
Créteil
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Düsseldorf
Country [13] 0 0
Germany
State/province [13] 0 0
Hanover
Country [14] 0 0
Germany
State/province [14] 0 0
Münster
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Christchurch
Country [17] 0 0
New Zealand
State/province [17] 0 0
Dunedin
Country [18] 0 0
Switzerland
State/province [18] 0 0
Bern
Country [19] 0 0
Switzerland
State/province [19] 0 0
Zürich
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Gregory Dore
Address 0 0
Kirby Institute, University of New South Wales Sydney, Australia
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?
No individual participant data will be shared. The results of the project will be presented at scientific meetings, and published in peer reviewed scientific literature. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We plan to make our results available to the community of scientists interested in recently acquired hepatitis C, community organisations representing the affected communities and participants. We also welcome collaboration with others who could make use of data and samples.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Submitted as part of J Hepatology accepted publication
Available to whom?
Access via the J Hepatology accepted publication
Available for what types of analyses?
How or where can data be obtained?


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/NCT03117569