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Completed

NCT Number: NCT01687270

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

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.

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Key information

Conditions

Recurrent Chronic Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post Liver Transplant RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Villejuif, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg tablet administered orally once daily

Other names: GS-7977, PSI-7977, Sovaldi®

RBV

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.

Other names: Ribasphere®

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.

  2. Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)

    Time frame: Posttreatment Weeks 4, 24, and 48

    SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24

    Time frame: Weeks 12 and 24

  3. HCV RNA and Change From Baseline at Weeks 2, 4, and 8

    Time frame: Baseline; Weeks 2, 4, and 8

  4. Percentage of Participants With Virologic Failure

    Time frame: Up to Posttreatment Week 24

    Virologic failure was defined as on-treatment virologic failure or virologic relapse.

    • On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
    • Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 18, 2012
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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