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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01687257




Registration number
NCT01687257
Ethics application status
Date submitted
12/09/2012
Date registered
18/09/2012
Date last updated
16/09/2016

Titles & IDs
Public title
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
Scientific 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
Secondary ID [1] 0 0
2012-002457-29
Secondary ID [2] 0 0
GS-US-334-0125
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Cirrhosis 0 0
Portal Hypertension 0 0
With or Without Liver Decompensation 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Hypertension
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SOF
Treatment: Drugs - RBV

Experimental: SOF+RBV - Participants will receive SOF+RBV for 48 weeks.

Experimental: Observation, then SOF+RBV - Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.


Treatment: Drugs: SOF
SOF 400 mg tablet administered orally once daily

Treatment: Drugs: RBV
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)
Secondary outcome [1] 0 0
Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
Timepoint [1] 0 0
Posttreatment Weeks 4, 24, and 48
Secondary outcome [2] 0 0
Percentage of Participants Experiencing On-Treatment Virologic Failure
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
Percentage of Participants Experiencing Viral Relapse
Timepoint [3] 0 0
Up to Posttreatment Week 24
Secondary outcome [4] 0 0
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment
Timepoint [4] 0 0
Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)
Secondary outcome [5] 0 0
Change From Baseline in Child-Pugh-Turcotte (CPT) Score
Timepoint [5] 0 0
Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
Secondary outcome [6] 0 0
Change From Baseline in Model for End Stage Liver Disease (MELD) Scores
Timepoint [6] 0 0
Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Newtown
Recruitment postcode(s) [1] 0 0
- Newtown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
France
State/province [5] 0 0
Clichy
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shampa De-Oertel, PhD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01687257