Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3
2 other identifiers
interventional
292
1 country
2
Brief Summary
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 13, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
November 17, 2014
CompletedNovember 17, 2014
November 1, 2014
2.8 years
December 13, 2010
November 7, 2014
November 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Up to 12 weeks plus 30 days
Secondary Outcomes (8)
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
Posttreatment Week 12
Percentage of Participants With HCV RNA < LOD at Week 6
Week 6
Percentage of Participants With HCV RNA < LOD at Week 8
Week 8
Percentage of Participants With HCV RNA < LOD at Week 12
Week 12
Change From Baseline in HCV RNA at Week 6
Baseline to Week 6
- +3 more secondary outcomes
Study Arms (22)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks.
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks.
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks.
Group 5: SOF 12 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks.
Group 7: SOF+RBV 12 wk: GT 1, TE
EXPERIMENTALTreatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Group 8: SOF+RBV 12 wk: GT 1, TN
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
EXPERIMENTALTreatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks.
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks.
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
EXPERIMENTALTreatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
EXPERIMENTALTreatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.
Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis
EXPERIMENTALTreatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis
EXPERIMENTALTreatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
EXPERIMENTALTreatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
EXPERIMENTALTreatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac
EXPERIMENTALHemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks.
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
EXPERIMENTALTreatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Interventions
Sofosbuvir (SOF) tablets administered orally once daily
Ribavirin (RBV) capsules administered orally in a divided daily dose
Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
Ledipasvir (LDV) tablets administered orally once daily
GS-9669 tablets administered orally once daily
LDV/SOF fixed-dose combination (FDC) tablet administered once daily
Eligibility Criteria
You may qualify if:
- Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL
- Not co-infected with HIV
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
You may not qualify if:
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of significant drug allergy to nucleoside/nucleotide analogs.
- Participation in a clinical study within 3 months prior to first dose
- Positive result for significant drug use at Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (2)
Auckland Clinical Studies Ltd.
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Related Publications (2)
Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM, Symonds WT, McHutchison JG, Pang PS. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014 Mar;146(3):736-743.e1. doi: 10.1053/j.gastro.2013.11.007. Epub 2013 Nov 18.
PMID: 24262278RESULTGane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.
PMID: 23281974RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Robert H. Hyland, DPhil
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2010
First Posted
December 15, 2010
Study Start
December 1, 2010
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
November 17, 2014
Results First Posted
November 17, 2014
Record last verified: 2014-11