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.

Phase 1

• Conditions: Chronic Hepatitis B; MedDRA version: 17.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024586-45-PT
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-09
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

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

Exclusion Criteria

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
Histroy 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