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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02862548




Registration number
NCT02862548
Ethics application status
Date submitted
8/08/2016
Date registered
11/08/2016

Titles & IDs
Public title
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
Scientific title
A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Subjects With Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
Secondary ID [1] 0 0
ACTRN12616000898459
Secondary ID [2] 0 0
GS-US-320-3912
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 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
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAF
Treatment: Drugs - TDF
Treatment: Drugs - Other approved antivirals

Experimental: TAF - TAF 25 mg once daily for 48 weeks

Active comparator: TDF-Containing Regimens - TDF alone or in combination with other approved antivirals per local practice for 48 weeks

Experimental: Optional Treatment Extension Phase - After Week 48, participants will be eligible to receive TAF 25 mg once daily for an additional 144 weeks.


Treatment: Drugs: TAF
Tablet administered orally

Treatment: Drugs: TDF
Tablet administered orally

Treatment: Drugs: Other approved antivirals
Other approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Percentage of Participants With HBV DNA < 20 IU/mL at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percent Change From Baseline in Hip BMD at Week 48
Timepoint [2] 0 0
Baseline, Week 48
Secondary outcome [3] 0 0
Percent Change From Baseline in Spine BMD at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Percent Change From Baseline in Spine BMD at Week 48
Timepoint [4] 0 0
Baseline, Week 48
Secondary outcome [5] 0 0
Change From Baseline in Serum Creatinine at Week 24
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change From Baseline in Serum Creatinine at Week 48
Timepoint [6] 0 0
Baseline, Week 48
Secondary outcome [7] 0 0
Change From Baseline in Serum eGFR_CKD-EPI at Week 48
Timepoint [7] 0 0
Baseline, Week 48
Secondary outcome [8] 0 0
Percentage of Participants With HBV DNA < 20 IU/mL at Week 48
Timepoint [8] 0 0
Week 48

Eligibility
Key inclusion criteria
Key

* Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
* Documented evidence of chronic HBV infection prior to transplantation
* Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
* Liver Transplant = 12 weeks prior to screening
* Maintained on TDF alone or in combination with other approved antivirals for HBV prophylaxis or treatment
* Have been on approved HBV oral antiviral (OAV) treatment for at least 12 weeks post-transplant prior to screening, with HBV DNA < lower limit of quantification (LLOQ) at screening
* Screening estimated glomerular filtration rate using the chronic kidney disease epidemiology collaboration (eGFR_CKD-EPI) < 90 ml/min/1.73m^2
* Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Women considered of child bearing potential must have a negative serum pregnancy test at Screening and a negative urine test at Baseline before dosing
* Must be willing and able to comply with all study requirements

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Multi-organ transplant that includes heart or lung recipient (participants who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
* Participants with history of de novo or recurrent hepatocellular carcinoma (HCC) post-transplant and at screening
* Histological evidence of unresolved transplant rejection
* Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
* Participants meeting any of the following laboratory parameters at screening:

* Alanine aminotransferase (ALT) > 10 × the upper limit of normal (ULN)
* International normalized ratio (INR) > 1.5 × ULN unless the participant is stable on anticoagulant regimen affecting INR
* Albumin < 3.0 g/dL
* Direct bilirubin = 4 × ULN
* Platelet count < 50,000/mL
* Co-infection with HIV or hepatitis C virus (HCV)
* Recent (within 4 weeks of Screening) episode or infection requiring systemic antibiotics
* Use of any prohibited medications listed within 28 days of the Baseline/Day 1 visit
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer, etc.) or hepatocellular carcinoma. Participants under evaluation for possible malignancy are not eligible
* Significant cardiovascular, pulmonary, or neurological disease
* Use of investigational agents within 3 months of screening, unless allowed by the Sponsor
* Use of any prohibited medications
* Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
* Known hypersensitivity to study drugs, metabolites or formulation excipients
* Lactating females or those who may wish to become pregnant during the course of the study

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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 2
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
16/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/05/2021
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy


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/NCT02862548