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Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients

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Gilead Sciences

Status and phase

Completed
Phase 2

Conditions

Hepatitis C

Treatments

Drug: Sofosbuvir
Drug: RBV
Drug: Placebo
Drug: PEG

Study type

Interventional

Funder types

Industry

Identifiers

NCT01054729
P7977-0221

Details and patient eligibility

About

Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Treatment-naive males and females, 18-65 years of age
  • Genotype 1 HCV infection
  • Negative pregnancy test for females of childbearing age
  • Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion criteria

  • Hepatitis B or HIV infection
  • Pregnant or breast feeding females or male partners of pregnant females
  • Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
  • History or evidence of medical condition associated with chronic liver disease other than HCV

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

64 participants in 4 patient groups

Sofosbuvir 100 mg+PEG+RBV
Experimental group
Description:
Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Treatment:
Drug: PEG
Drug: Sofosbuvir
Drug: RBV
Sofosbuvir 200 mg+PEG+RBV
Experimental group
Description:
Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Treatment:
Drug: PEG
Drug: Sofosbuvir
Drug: RBV
Sofosbuvir 400 mg+PEG+RBV
Experimental group
Description:
Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Treatment:
Drug: PEG
Drug: Sofosbuvir
Drug: RBV
Placebo+PEG+RBV
Active Comparator group
Description:
Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Treatment:
Drug: PEG
Drug: Placebo
Drug: RBV

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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