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 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-NL
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-27
• Last Update Posted: 14 September 2015

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 = 20,000 IU/ml for HBeAg+ subjects and HBV
DNA = 2,000 IU/ml for HBeAg- subjects.

ALT > 54 U/L and = 400 U/L for men and > 36 U/L and
= 300 U/L for women.

Creatinine clearance rate = 80 mL/min.

A negative serum pregnancy test is required for female subjects of childbearing potential.

All sexually active female subjects 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 female subjects must agree to discontinue nursing before initiation of study investigational medicinal product.
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

Evidence of bridging fibrosis or cirrhosis at screening as confirmed by liver biopsy within 12 months prior to first visit. In countries where Fibroscan is approved for clinical
use, Fibroscan (< 8 kPa) may be used to verify absence of bridging fibrosis and cirrhosis. Patients with Fibroscan data of > 8 kPa will be excluded, unless biopsy within the 12 months prior to first visit confirms the absence of bridging fibrosis and cirrhosis.

Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × ULN, PT > 1.2 × ULN, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage). Isolated
increase in direct bilirubin >6.1 µmol/L but < 10.2 µmol/L, in the presence of platelet count >100,000/mm3 and normal INR, may qualify for the trial.

Absolute neutrophil count < 1,500/mm3, platelet < 100,000/mm3, hemoglobin < 10 g/dL for female subjects or < 11 g/dL for male subjects Evidence of hepatocellular carcinoma.

Evidence of hepatocellular carcinoma.

History of severe depression or known severe psychiatric disease.

History of significant renal disease (e.g., nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal
disease).

Thyroid dysfunction.

History of autoimmune disease (e.g., lupus, rheumatoid arthritis, autoimmune thyroiditis).

Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, history of multiple bone fractures).

Pregnant.

Previous treatment with any form of interferons and anti-HBV nucleotides.

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.

Known hypersensitivity to the study investigational medicinal product, metabolites, or formulation excipients.

Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified