Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments tdf, peg
Phase phase 4
Sponsor Gilead Sciences
Start date April 2011
End date August 2014
Trial size 751 participants
Trial identifier NCT01277601, GS-US-174-0149

Summary

This study will evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG monotherapy in non-cirrhotic adults with chronic hepatitis B virus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive TDF plus PEG concomitantly for 48 weeks.
tdf Viread®
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily
peg Pegasys®
Peginterferon α-2a (PEG) 180 µg administered via subcutaneous injection once weekly
(Experimental)
Participants will receive TDF plus PEG concomitantly for 16 weeks, followed by TDF alone for 32 weeks (total 48 weeks).
tdf Viread®
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily
peg Pegasys®
Peginterferon α-2a (PEG) 180 µg administered via subcutaneous injection once weekly
(Active Comparator)
Participants will receive TDF continuously through 120 weeks.
tdf Viread®
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily
(Active Comparator)
Participants will receive PEG for 48 weeks.
peg Pegasys®
Peginterferon α-2a (PEG) 180 µg administered via subcutaneous injection once weekly

Primary Outcomes

Measure
Proportion of participants with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone
time frame: Week 72

Secondary Outcomes

Measure
Proportion of participants with HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone
time frame: Week 72
Proportion of participants who experience HBsAg loss at Week 96 and Week 120
time frame: Weeks 96 and 120
Proportion of participants with virological response (hepatitis B virus [HBV] DNA level < 117 IU/mL) at Weeks 72, 96, and 120
time frame: Weeks 72, 96, and 120
Proportion of participants with serological response (HBeAg loss and seroconversion, and HBsAg seroconversion) at Weeks 72, 96, and 120
time frame: Weeks 72, 96, and 120
Proportion of participants who experience biochemical response at Weeks 72, 96, and 120
time frame: Weeks 72, 96, and 120
Proportion of participants who require reinitiation or change of anti-HBV therapy while on therapy or posttreatment
time frame: Up to 120 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Adults (aged 18-75) with CHB (positive for serum HBsAg or HBV DNA for at least 6 months) prior to baseline. - Anti-HBV treatment naive adults and adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible. - Positive or negative for HBeAg -HBV DNA ≥ 20,000 IU/ml for individuals with HBeAg+ and HBV DNA ≥ 2,000 IU/ml for individuals with HBeAg- - ALT >54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women - Creatinine clearance ≥ 70 mL/min - A negative serum pregnancy test is required for females of childbearing potential - All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual intercourse throughout the study and for 30 days following the last dose of study medication. - Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product. Exclusion Criteria: - Known bridging fibrosis or cirrhosis and/or decompensated liver disease - Evidence of hepatocellular carcinoma - Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures) - Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male) - History of severe depression or severe psychiatric disease - Thyroid dysfunction - Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV) - Pregnant

Additional Information

Official title A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.