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

September 12, 2012
January 7, 2014
November 2012
August 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01687257 on ClinicalTrials.gov Archive Site
  • 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
  • Change in Hepatic Venous Pressure Gradient (HVPG) measurements [ Time Frame: Baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]
    Determine the effect of 24 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
Not Provided
Not Provided
 
GS-7977 and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Cirrhosis
  • Portal Hypertension
  • With or Without Liver Decompensation
  • Drug: GS-7977
    Other Name: sofosbuvir
  • Drug: Ribavirin
    Other Name: RBV
  • Active Comparator: GS-7977 and Ribavirin
    48 weeks of GS 7977 400 mg QD + RBV (1000 or 1200 mg/day) BID
    Interventions:
    • Drug: GS-7977
    • Drug: Ribavirin
  • 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
    Interventions:
    • Drug: GS-7977
    • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
May 2015
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   New Zealand,   Spain
 
NCT01687257
GS-US-334-0125
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP