Chronic Hepatitis C Infection Clinical Trial
Official title:
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
Verified date | November 2014 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | New Zealand: Medsafe |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 292 |
Est. completion date | December 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
New Zealand | Auckland Clinical Studies Ltd. | Auckland | |
New Zealand | Christchurch Clinical Studies Trust | Christchurch |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
New Zealand,
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 — View Citation
Gane 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug. | Posttreatment Week 12 | No |
Secondary | Percentage of Participants With HCV RNA < LOD at Week 6 | Week 6 | No | |
Secondary | Percentage of Participants With HCV RNA < LOD at Week 8 | Data are not presented for Group 21 which ended treatment after Week 6. | Week 8 | No |
Secondary | Percentage of Participants With HCV RNA < LOD at Week 12 | Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. | Week 12 | No |
Secondary | Change From Baseline in HCV RNA at Week 6 | Baseline to Week 6 | No | |
Secondary | Change From Baseline in HCV RNA at Week 8 | Data are not presented for Group 21 which ended treatment after Week 6. | Baseline to Week 8 | No |
Secondary | Change From Baseline in HCV RNA at Week 12 | Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules. | Baseline to Week 12 | No |
Secondary | Percentage of Participants With Virologic Failure | The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized. On-treatment virologic failure was defined as: Viral breakthrough (confirmed HCV RNA = LOD after having previously had HCV RNA < LOD while on treatment), Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or Nonresponse (HCV RNA persistently = LOD through 6 weeks of treatment) Viral relapse was defined as confirmed HCV RNA = LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit. |
Up to Posttreatment Week 24 | No |
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