A study in people with long-lasting hepatitis B to assess the effectiveness and safety of a combination of the two drugs Viread and Pegasys compared with each drug given on its own.
- Conditions
- Chronic Hepatitis BMedDRA version: 17.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-024586-45-PL
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline.
Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible.
HBV DNA for HBeAg- >= 2000 IU/ml and HBeAg+ subjects >= 20000 IU/ml.
ALT > 54 U/L and <= 400 U/L for men, and > 36 U/L and <= 300 U/L for women.
Creatinine clearance rate greater than or equal to 80 mL/min
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 706
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
Known bridging fibrosis or cirrhosis and/or decompensated liver disease
Decompensated liver disease
Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
Evidence of hepatocellular carcinoma
History of significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
History of severe depression or severe psychiatric disease
Thyroid dysfunction
Co-infection with HIV, HCV or HDV
Ongoing therapy with any of the following:
• Nephrotoxic agents
— Parenteral aminoglycoside antibiotics (e.g., gentamicin, tobramycin,
amikacin)
— Cidofovir
— Cisplatin
— Foscarnet
— IV amphotericin B
— IV pentamidine
— Oral or IV ganciclovir
— Cyclosporine
— Tacrolimus
— IV vancomycin
— Chronic daily non-steroidal anti-inflammatory drug therapy
• Hepatotoxic agents such as anabolic steroids, isoniazid, itraconazole,
ketoconazole, rifabutin, rifampin and other agents with significant
hepatotoxic potential
• Competitors of renal excretion (e.g., probenecid)
• Systemic chemotherapeutic agents
• Systemic corticosteroids
• Interleukin-2 (IL-2) and other immunomodulating agents
• Investigational agents (except with the expressed approval of the
Sponsor)
Administration of any of the above mentioned medications must be
discontinued at least 30 days prior to the Baseline Visit and for the
duration of the study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon a-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined by loss of HBsAg.;Secondary Objective: Efficacy of TDF (48 weeks) plus PEG (16 weeks) combination therapy versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined by loss of HBsAg<br><br>Serological responses (HBeAg loss and seroconversion, and HBsAg seroconversion)<br><br>Biochemical responses (ALT levels)<br><br>Virological response (HBV DNA < 400 copies / mL) [< 117 IU/mL]);Primary end point(s): The proportion of subjects 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.;Timepoint(s) of evaluation of this end point: Week 72
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of subjects 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<br><br>The proportion of subjects who experience HBsAg loss at Week 96 and Week 120<br><br>The rate of quantitative HBsAg decline during the study<br><br>The proportion of subjects with virological response (HBV DNA level <400 copies/mL [< 117 IU/mL]) at Weeks 72, 96 and 120<br><br>The proportion of subjects with serological response (HBeAg loss and seroconversion, and HBsAg seroconversion) at Weeks 72, 96 and 120<br><br>The proportion of subjects who experience biochemical response (ALT<ULN) at Weeks 72, 96 and 120<br><br>The proportion of subjects who require re-initiation or change of therapy while on therapy or post-treatment;Timepoint(s) of evaluation of this end point: Weeks 72, 96 and/or 120<br>