Trial · NCT01616524
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
NCT01616524, Phase 3, Completed, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3. Trials, record NCT01616524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01616524
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
- NCT number
- NCT01616524
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 880 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis C Virus (HCV)
- Interventions
- Pegylated interferon lambda (pegIFNλ), Pegylated interferon lambda (pegIFNλ), Pegylated interferon alfa-2a (pegIFNα-2a), Ribavirin, Ribavirin, Daclatasvir, Placebo matching Daclatasvir
- First posted
- 2012-06-11
- Last updated
- 2015-10-09
- Other registries' IDs
- eudract:2011-004885-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) | Post-treatment follow-up week 12 | |
| Secondary | Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] | On-treatment Week 4 | |
| Secondary | Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) | Up to week 12 or week 24 | Hb = Hemoglobin ANC = Absolute neutrophil count |
| Secondary | Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) | Up to week 12 or week 24 | |
| Secondary | Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) | Up to week 12 or week 24 | |
| Secondary | Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group | Post-treatment week 24 | |
| Secondary | Proportion of subjects with on-treatment Serious adverse events (SAEs) | Up to week 12 or week 24 | |
| Secondary | Proportion of subjects with dose reductions | Up to week 12 or week 24 | |
| Secondary | Proportion of subjects who discontinue due to Adverse events (AEs) | Up to week 12 or week 24 | |
| Secondary | Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection | Post-treatment follow-up week 12 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT01616524
GET https://conductscience.org/api/trials/v1/NCT01616524/registered