Sofosbuvir 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: June 11, 2014
Last verified: June 2014

September 12, 2012
June 11, 2014
December 2012
January 2015   (final data collection date for primary outcome measure)
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
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).
Complete list of historical versions of study NCT01687257 on ClinicalTrials.gov Archive Site
  • Change in Hepatic Venous Pressure Gradient (HVPG) measurements [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: No ]
  • Change in Child-Pugh-Turcotte (CPT) score [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: No ]
  • Change in Model for End-Stage Liver Disease (MELD) score [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with sustained virologic response at 4, 24, and 48 weeks after discontinuation of therapy (SVR4, SVR24, SVR48) [ Time Frame: Posttreatment Weeks 4, 24, and 48 ] [ Designated as safety issue: No ]
    SVR4, SVR24, SVR48 are defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
  • Proportion of participants experiencing viral breakthrough [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: No ]
    Viral breakthrough is defined as having HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (note, second confirmation value can be posttreatment), or last available on-treatment measurement with no subsequent follow up values.
  • Proportion of participants experiencing viral relapse [ Time Frame: Week 48 to Posttreatment Week 48 ] [ Designated as safety issue: No ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.
  • 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
 
Sofosbuvir 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 study will evaluate the antiviral efficacy of combination therapy with sofosbuvir+ribavirin for 48 weeks in adults with compensated and decompensated chronic HCV infection. Approximately 50 adults will be randomized (1:1) to 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: Sofosbuvir
    Sofosbuvir 400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977
  • Drug: Ribavirin
    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
  • Experimental: Sofosbuvir+ribavirin
    Participants will receive sofosbuvir plus ribavirin for 48 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: Ribavirin
  • Experimental: Observation, then sofosbuvir+ribavirin
    Participants will undergo 24 weeks of observation and then receive sofosbuvir plus ribavirin for 48 additional weeks.
    Interventions:
    • Drug: Sofosbuvir
    • 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
October 2015
January 2015   (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
Australia,   United States,   Spain,   France,   New Zealand
 
NCT01687257
GS-US-334-0125, 2012-002457-29
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Jill M. Denning, MA Gilead Sciences
Gilead Sciences
June 2014

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