A study looking at 12 weeks treatment with GS-7977 + Ribavirin for patients with chronic genotype 2 or 3 Hepatitis C infection.

• Conditions: Chronic Genotype 2 or 3 HCV Infection; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-001942-16-SE
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-08
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Male or female, age = 18 years
3. Confirmation of chronic HCV infection
4. Classification as treatment naïve or treatment experienced
5. Cirrhosis determination (approximately 20% of subjects may have cirrhosis)
6. Liver imaging within 6 months of Baseline/Day 1 (required in cirrhotic patients only, to exclude hepatocellular carcinoma)
7. Infection with HCV genotype 2 or 3 as determined at Screening
8. HCV RNA = 10e4 IU/mL at Screening
9. Body mass index (BMI) = 18 kg/m2
10. Screening ECG without clinically significant abnormalities
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Prior exposure to a direct-acting antiviral targeting the HCV NS5B polymerase
2. Pregnant or nursing female or male with pregnant female partner
3. Chronic liver disease of a non-HCV etiology
4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
5. Contraindication to RBV therapy
6. History of malignancy diagnosed or treated within 5 years; subjects under evaluation for malignancy are not eligible
7. History of clinically significant hemoglobinopathy
8. Chronic use of systemically administered immunosuppressive agents
9. Clinically-relevant drug or alcohol abuse within 12 months of screening.
10. History of solid organ transplantation
11. Current or prior history of clinical hepatic decompensation

Study & Design

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