Clinical trial NCT01687257: Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Cirrhosis
Portal Hypertension
With or Without Liver Decompensation
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (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.


Eligibility criteria: Inclusion Criteria:

* Chronic infection with Hepatitis C with HCV RNA \> 1000 IU/mL
* Individuals 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/m\^2
* 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)
Secondary outcomes:
measure: Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
timeFrame: Posttreatment Weeks 4, 24, and 48
measure: Percentage of Participants Experiencing On-Treatment Virologic Failure
timeFrame: Up to 48 weeks
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 24
measure: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment
timeFrame: Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)
measure: Change From Baseline in Child-Pugh-Turcotte (CPT) Score
timeFrame: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
measure: Change From Baseline in Model for End Stage Liver Disease (MELD) Scores
timeFrame: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Philadelphia
country: United States
state: Pennsylvania
city: Newtown
country: Australia
state: New South Wales
city: Leclerc
country: France
state: Clichy
city: Grafton
country: New Zealand
state: Auckland
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
Study officials:
affiliation: Gilead Sciences
name: Shampa De-Oertel, PhD
role: STUDY_DIRECTOR
References: