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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01687270




Registration number
NCT01687270
Ethics application status
Date submitted
12/09/2012
Date registered
18/09/2012
Date last updated
19/12/2014

Titles & IDs
Public title
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
Scientific title
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant
Secondary ID [1] 0 0
2012-002417-19
Secondary ID [2] 0 0
GS-US-334-0126
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Chronic Hepatitis C Virus 0 0
Post Liver Transplant 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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - RBV

Experimental: SOF+RBV - Participants will receive sofosbuvir+RBV for 24 weeks.


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

Treatment: Drugs: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
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 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response (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 With HCV RNA < LLOQ at Weeks 12 and 24
Timepoint [2] 0 0
Weeks 12 and 24
Secondary outcome [3] 0 0
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Timepoint [3] 0 0
Baseline; Weeks 2, 4, and 8
Secondary outcome [4] 0 0
Percentage of Participants With Virologic Failure
Timepoint [4] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
- Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation

- HCV RNA = 10,000 IU/mL at screening

- Absence of organ rejection as documented by post transplant liver biopsy taken no more
than 12 months prior to baseline/Day 1 visit

- Liver transplant = 6 months and = 12 years prior to screening

- Naive to all nucleotide/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
- Multiorgan transplant that includes heart or lung recipient

- Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant

- Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose
of corticosteroid)

- Infection with hepatitis B virus (HBV) or HIV at screening

- Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy,
hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated
cirrhosis

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
France
State/province [8] 0 0
Villejuif
Country [9] 0 0
Germany
State/province [9] 0 0
Lower Saxony
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults
who have had a liver transplant which has become re-infected with hepatitis C. The treatment
period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last
up to 72 weeks not including the screening visit.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01687270
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jill M. Denning, MA
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01687270