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

Post Liver Transplant Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687270
• Other study ID #: GS-US-334-0126
• Secondary ID: 2012-002417-19
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2012
• Last updated: December 11, 2014
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Post Liver Transplant
• Recurrent Chronic Hepatitis C Virus

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  France,  Germany,  New Zealand,  Spain, 

References & Publications (1)

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 tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	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.	Posttreatment Week 12	No
Primary	Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event		Baseline to Week 24	No
Secondary	Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)	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.	Posttreatment Weeks 4, 24, and 48	No
Secondary	Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24		Weeks 12 and 24	No
Secondary	HCV RNA and Change From Baseline at Weeks 2, 4, and 8		Baseline; Weeks 2, 4, and 8	No
Secondary	Percentage of Participants With Virologic Failure	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)	Up to Posttreatment Week 24	No