Trial · NCT01309932
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
NCT01309932, Phase 2, Completed, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin. Trials, record NCT01309932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01309932
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
- NCT number
- NCT01309932
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis C
- Interventions
Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor), Ribavirin (RBV), BMS-650032 (NS3 Protease Inhibitor), Pegylated Interferon Alfa-2a (pegIFNα-2a), Pegylated Interferon Lambda (pegIFNλ), Ribavirin (RBV), Pegylated Interferon Lambda (pegIFNλ), Ribavirin (RBV), BMS-790052 (NS5A Inhibitor), BMS-650032 (NS3 Protease Inhibitor), Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor), Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor), Placebo for Ribavirin (RBV), Placebo for Ribavirin (RBV)
- First posted
- 2011-03-07
- Last updated
- 2015-10-09
- Other registries' IDs
- eudract:2010-022568-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs) | Up to end of treatment ( maximum of 48 weeks) plus 30 days | |
| Primary | Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24) | At end of treatment (maximum of 48 weeks) | |
| Primary | Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24) | Post-treatment Week 24 | |
| Secondary | Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B | Weeks 4, Weeks 12 and post-treatment Weeks 24 | * Part A PDR is defined as HCV RNA at Week 4 \< LLOQ and Week 12 undetectable * Part B PDR is defined as HCV RNA at Week 2 ≥ 2 log10 decrease (or \< Lower limit of quantitation (LLOQ) if baseline HCV RNA \< 2400 IU/mL), Week 4 \< LLOQ and Week 12 undetectable |
| Secondary | Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA | Weeks 2, Weeks 4 and Weeks 12 | |
| Secondary | Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA ≥ Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment | Post-treatment Week 48 | |
| Secondary | Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period | Post-treatment Week 48 | |
| Secondary | Serum HCV Ribonucleic acid (RNA) levels over time | Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment) | |
| Secondary | Proportion of subjects with undetectable HCV RNA over time | Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment) | |
| Secondary | Time to viral clearance, defined as an absence of detectable HCV RNA | Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01309932
GET https://conductscience.org/api/trials/v1/NCT01309932/registered