GS-7977 and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
This study is currently recruiting participants.
Verified April 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01687257
First received: September 12, 2012
Last updated: April 30, 2013
Last verified: April 2013
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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 |
Access to an investigational treatment associated with this study is available outside the clinical trial. 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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
Drug Information available for:
Ribavirin
U.S. FDA Resources
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
| Estimated 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
Contacts
| Contact: Jonathan Kong | 334-0125alertsalerts@gilead.com |
Locations
| United States, Colorado | |
| Recruiting | |
| Aurora, Colorado, United States | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| Recruiting | |
| Rochester, Minnesota, United States | |
| United States, Pennsylvania | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States | |
| Australia, New South Wales | |
| Recruiting | |
| Newtown, New South Wales, Australia | |
| France | |
| Not yet recruiting | |
| Leclerc, Clichy, France | |
| New Zealand | |
| Recruiting | |
| Grafton, Auckland, New Zealand | |
| Spain | |
| Recruiting | |
| Majadahonda, Madrid, Spain | |
| Recruiting | |
| 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: | April 30, 2013 |
| 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 May 19, 2013