A study with GS-7977 and Ribavirin in Hepatitis C patients with cirrhosis and portal hypertensio

• Conditions: Subjects infected with chronic HCV with cirrhosis and portal hypertension with or without liver decompensation; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-002457-29-ES
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-31
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Age ?18 years
3. Subjects with compensated cirrhosis (CPT Score 5-6) or decompensated cirrhosis (CPT Score 7-10) with the presence of esophageal or gastric varices on endoscopy
4. Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg
5. HCV RNA > 103 IU/mL at Screening
6. Body mass index (BMI) ?18 kg/m2
7. Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
8. Non-pregnant, non-nursing female
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 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Any serious or active medical or psychiatric illness
2. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
3. AFP > 50 unless negative imaging for hepatic masses
4. Malignancy within the 5 years prior to screening
5. Refractory ascites as defined by requiring paracentesis > twice
6. Prior placement of a portosystemic shunt (such as TIPS)
7. Imaging evidence or history of portal vein thrombosis
8. Active variceal bleeding within 6 months of screening
9. Expected survival of < 1 year
11. Chronic use of systemic immunosuppressive agents
17. Evidence of renal impairment (CrCl < 50 mL/min) using the Cockcroft-Gault equation

Study & Design

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