A study of GS-7977 and Ribavirin in patients who have hepatitis C and have received a liver transplant

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002417-19-DE

Enrollment

Registered

2012-09-11

Start date

2012-12-12

Completion date

Unknown

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Chronic HCV Post Liver Transplant MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Sofosbuvir Product Code: GS-7977 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sofosbuvir CAS Number: 1190307-88-0 Current Sponsor code: GS-7977 Concentration unit: mg mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Willing and able to provide written informed consent 2. Males or females, age = 18 years old 3. Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation 4. HCV RNA = 10000 IU/mL at screening 5. Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to Baseline/Day 1 visit 6. Primary or secondary (retransplant), liver alone or liver and kidney transplant recipient from deceased or living donor (regardless of the HCV status of the liver donor) 7. Liver transplant = 6 months and = 150 months prior to screening 8. Naïve to all nucleotides/nucleoside treatments for chronic HCV infection 9. A body mass index (BMI) of =18 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: 1. Multi-organ transplant that includes heart or lung recipient 2. Subjects with de novo or recurrent Hepatocellular Carcinoma (HCC) post transplant based on center specific screening protocol 3. Current use of corticosteroids at any dose = 5mg of prednisone/day (or equivalent dose of corticosteroid) 4. Child-Pugh-Turcotte Score CPT > 7 at screening 5. MELD score > 17 at screening 6. Recipient of ABO incompatible organ 7. Histological evidence of unresolved rejection 8. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) at screening 9. Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis 10. Serum creatinine >2.5x upper limit of normal or stage 4 chronic kidney disease (CrCl <30ml/min) 18. Treatment with IFN, RBV, telaprevir or boceprevir or any other approved or experimental medication with known anti-HCV activity within 3 months prior to Baseline/Day 1 visit 19. Screening ECG with clinically significant abnormalities 20. Participation in a clinical study with an investigational drug, or biologic within 3 months prior to first dose administration at the Baseline/Day 1 Visit

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the antiviral efficacy of combination therapy with GS-7977 + ribavirin for 24 weeks in subjects with recurrent HCV post liver transplant as measured by sustained virologic response 12 weeks after discontinuation of therapy (SVR12 defined as HCV RNA < lower limit of quantitation [LLoQ] 12 weeks after last dose of study drug).;Secondary Objective: • To evaluate the safety and tolerability of this regimen in this patient population • To determine the proportion of subjects who attain sustained virologic response at 4, 24 and 48 weeks after discontinuation of therapy (SVR4, SVR24 and SVR48) • To evaluate the emergence of viral resistance to GS-7977 during and after treatment discontinuation. • To evaluate the kinetics of circulating HCV RNA during and after treatment;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < lower limit of quantitation [LLoQ] 12 weeks after last dose of study drug) for subjects in the Full Analysis Set.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug	—

Measure

Time frame

Main Objective: To determine the antiviral efficacy of combination therapy with GS-7977 + ribavirin for 24 weeks in subjects with recurrent HCV post liver transplant as measured by sustained virologic response 12 weeks after discontinuation of therapy (SVR12 defined as HCV RNA < lower limit of quantitation [LLoQ] 12 weeks after last dose of study drug).;Secondary Objective: • To evaluate the safety and tolerability of this regimen in this patient population • To determine the proportion of subjects who attain sustained virologic response at 4, 24 and 48 weeks after discontinuation of therapy (SVR4, SVR24 and SVR48) • To evaluate the emergence of viral resistance to GS-7977 during and after treatment discontinuation. • To evaluate the kinetics of circulating HCV RNA during and after treatment;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < lower limit of quantitation [LLoQ] 12 weeks after last dose of study drug) for subjects in the Full Analysis Set.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy endpoints include the proportion of subjects who attain sustained virologic response at 4, 24 and 48 weeks after discontinuation of therapy (SVR4, SVR24 and SVR48); proportion of subjects who have HCV RNA < LLoQ by visit while on treatment; absolute and change from baseline in HCV RNA through Week 8; and virologic failure.;Timepoint(s) of evaluation of this end point: 4, 24 and 48 weeks after last dose of study drug	—

Measure

Time frame

Secondary end point(s): The secondary efficacy endpoints include the proportion of subjects who attain sustained virologic response at 4, 24 and 48 weeks after discontinuation of therapy (SVR4, SVR24 and SVR48); proportion of subjects who have HCV RNA < LLoQ by visit while on treatment; absolute and change from baseline in HCV RNA through Week 8; and virologic failure.;Timepoint(s) of evaluation of this end point: 4, 24 and 48 weeks after last dose of study drug

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Countries

Germany, New Zealand, Spain, United States

Contacts

Public ContactMedical Monitor

Gilead Sciences Inc

clinical.trials@gilead.com+1650574 3000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026