A study to evaluate how different combinations of antiviral agents, when given with standard medicines, affect the treatment outcome of patients infected with the Hepatitis C Virus (HCV).

• Conditions: Genotype 1 Hepatitis C Virus Infection; MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-000456-42-CZ
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-29
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Male or female, aged from 18 to 70 years old
3. Chronic HCV infection
5. Monoinfection with HCV GT 1
6. HCV RNA > 10e4 IU/mL
7. HCV treatment naïve
8. Candidate for PEG/RBV therapy.
9. Body mass index (BMI) between 18 and 36 kg/m2
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Pregnant female or male with pregnant female partner
2. Poorly-controlled diabetes mellitus
3. History of clinically significant hemoglobinopathy
4. History of clinically significant retinal disease
5. History of invasive malignancy diagnosed or treated within 5 years
6. Untreated or significant psychiatric illnesses
7. Contraindications for PEG or RBV therapy
8. Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
9. Chronic use of systemically administered immunosuppressive agents
10. Presence of autoimmune disorders
11. Severe chronic obstructive pulmonary disease
12. History of significant cardiac disease
13. Known cirrhosis
14. Chronic liver disease of a non-HCV etiology
15. History of solid organ transplantation
16. Suspicion of hepatocellular carcinoma
17. Current or prior history of clinical hepatic decompensation

Study & Design

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