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Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

NCT ID: NCT01687270

Last Updated: 2014-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Chronic Hepatitis C Virus Post Liver Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF+RBV

Participants will receive sofosbuvir+RBV for 24 weeks.

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

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.

Interventions

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Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

Intervention Type DRUG

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 Type DRUG

Other Intervention Names

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GS-7977 PSI-7977 Sovaldi® Ribasphere®

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill M. Denning, MA

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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San Francisco, California, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Kansas City, Kansas, United States

Site Status

Boston, Massachusetts, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Rochester, Minnesota, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

Villejuif, , France

Site Status

Hanover, Lower Saxony, Germany

Site Status

Grafton, Auckland, New Zealand

Site Status

Barcelona, Barcelona, Spain

Site Status

Countries

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United States France Germany New Zealand Spain

References

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Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7.

Reference Type RESULT
PMID: 25304641 (View on PubMed)

Other Identifiers

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2012-002417-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-334-0126

Identifier Type: -

Identifier Source: org_study_id