GS-7977 and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01687257
First received: September 12, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

This is a multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 weeks in Patients Infected with Chronic HCV with Cirrhosis and Portal Hypertension with or without Liver Decompensation. Approximately 50 subjects (25 per group) will be randomized (1:1) to either receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.


Condition Intervention Phase
Hepatitis C
Cirrhosis
Portal Hypertension
With or Without Liver Decompensation
Drug: GS-7977
Drug: Ribavirin
Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Sustained virologic response 12 weeks after discontinuation of therapy. [ Time Frame: 12 weeks after discontinuation of therapy (SVR12) ] [ Designated as safety issue: No ]
    Sustained virologic response 12 weeks after discontinuation of therapy (SVR12 defined as HCV RNA < lower limit of quantification [LLoQ] 12 weeks after last dose of study drug).


Secondary Outcome Measures:
  • Change in Hepatic Venous Pressure Gradient (HVPG) measurements [ Time Frame: Baseline and after 48 weeks of treatment ] [ Designated as safety issue: No ]
    Determine the effect of 48 weeks of treatment on portal pressure as measured by Hepatic Venous Pressure Gradient (HVPG) measurements

  • Frequency and severity of adverse events [ Time Frame: Safety and Tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: No ]
    Assess safety laboratory tests and the number, frequency and severity of adverse events through 30 days post last dose of study drug


Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GS-7977 and Ribavirin
48 weeks of GS 7977 400 mg QD + RBV (1000 or 1200 mg/day) BID
Drug: GS-7977
Other Name: sofosbuvir
Drug: Ribavirin
Other Name: RBV
Active Comparator: 24wk observation then 7977 and Ribavirin
24 weeks of Observation, then 48 weeks GS 7977 QD + RBV (1000 or 1200 mg/day) BID
Drug: GS-7977
Other Name: sofosbuvir
Drug: Ribavirin
Other Name: RBV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL
  • Subjects with cirrhosis with Child-Pugh score < 10.
  • esophageal or gastric varices on endoscopy within 6 months prior to or at screening
  • Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg
  • Body mass index (BMI) >/= 18 kg/m2
  • Naïve to all nucleotides/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

  • Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
  • HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
  • Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
  • Refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
  • Active variceal bleeding within 6 months of screening
  • Expected survival of < 1 year
  • History of hepatorenal, or hepatopulmonary syndrome.
  • Evidence of renal impairment (CrCl < 50 mL/min)
  • History of major organ transplantation, including liver transplant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687257

Locations
United States, Colorado
Aurora, Colorado, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Australia, New South Wales
Newtown, New South Wales, Australia
France
Leclerc, Clichy, France
New Zealand
Grafton, Auckland, New Zealand
Spain
Majadahonda, Madrid, Spain
Barcelona, Spain
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01687257     History of Changes
Other Study ID Numbers: GS-US-334-0125
Study First Received: September 12, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Liver Failure
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Hepatic Insufficiency
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014