Trial · NCT01718158
Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
NCT01718158, Phase 3, Completed, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy. Trials, record NCT01718158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01718158
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
- NCT number
- NCT01718158
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 444 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis C
- Interventions
- Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin, Daclatasvir, Telaprevir
- First posted
- 2012-10-31
- Last updated
- 2015-10-09
- Other registries' IDs
- eudract:2011-005409-65
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12) | Post treatment follow-up Week 12 | |
| Secondary | Proportion of subjects who achieve SVR12 in treatment-naive subjects | Post treatment follow-up Week 12 | |
| Secondary | Proportion of subjects with rash related dermatologic events | Up to 12 weeks of treatment | |
| Secondary | Proportion of subjects who develop treatment emergent cytopenic abnormalities | Up to 48 Weeks | Treatment emergent cytopenic abnormalities \[anemia as defined by Hemoglobin (Hb) \< 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) \< 750/mm3, and or thrombocytopenia as defined by platelets \< 50,000/mm3\] |
| Secondary | Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms | Up to 48 Weeks | |
| Secondary | Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24 | Post treatment follow-up Week 24 | SVR24 = Sustained virologic response at post treatment follow-up Week 24 |
| Secondary | Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up | Maximum of 72 weeks | |
| Secondary | Proportion of subjects who achieve SVR12 with a 24-week treatment regimen | Post treatment follow-up Week 12 | |
| Secondary | Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment) | Weeks 4 and 12 of treatment | |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up | Maximum of 72 weeks |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27327078 | DERIVED |
Source PubMed
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/NCT01718158
GET https://conductscience.org/api/trials/v1/NCT01718158/registered