Trial · NCT01866930
Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV
NCT01866930, Phase 3, Terminated, Bristol-Myers Squibb; results first posted 2023-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV. Trials, record NCT01866930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01866930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV
- NCT number
- NCT01866930
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 453 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Hepatitis C Infection
- Interventions
- Pegylated Interferon Lambda-1a, Daclatasvir (DCV), Ribasphere (RBV)
- First posted
- 2013-06-03
- Last updated
- 2023-06-13
- Other registries' IDs
- eudract:2012-003280-22
- Results first posted
- 2023-06-13
- Limitations and caveats
- The study was ended prematurely, giving few participants an opportunity to reach follow-up week 24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Follow-up week 12 | SVR12 was defined as HCV RNA less than lower limit of quantification (\< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12. |
| Secondary | Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Treatment weeks 4 and 12 | RVR is defined as HCV RNA \< LLOQ target not detected at Week 4 and eRVR defined as HCV RNA \< LLOQ target not detected at Weeks 4 and 12 |
| Secondary | Number of Subjects With Sustained Virologic Response at Post-treatment Week 24 (SVR24) | Follow-up week 24 | SVR24 was defined as HCV RNA \< LLOQ (25 IU/mL; target detected or not detected) at 24 weeks post treatment. |
| Secondary | Number of Participants With Treatment Emergent Cytopenic Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | All treated participants were monitored for 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) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits). |
| Secondary | Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms | After Day 1 to end of treatment; up to Weeks 24 or 48 | All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits). |
| Secondary | Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs) | After Day 1 to end of treatment; up to Weeks 24 or 48 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that. at any dose, results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. |
| Secondary | Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | Grade 3/4 treatment-emergent lab abnormalities that occurred in \>=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase. |
| Secondary | Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. |
| Secondary | Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. |
| Secondary | Mean Change in Total Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Follow-up week 12 | The analysis was performed in all treated subjects using modified intent-to-treat algorithm, where the numerator is based on subjects meeting the response criteria and the denominator is based on all treated subjects (Non-completer = Failure). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Treatment weeks 4 and 12 | The analysis was performed in all treated subjects using modified intent-to-treat algorithm, where the numerator is based on subjects meeting the response criteria and the denominator is based on all treated subjects (Non-completer = Failure). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Sustained Virologic Response at Post-treatment Week 24 (SVR24) | Follow-up week 24 | The analysis was performed in all treated subjects using modified intent-to-treat algorithm (numerator is based on subjects meeting the response criteria and the denominator is based on all treated subjects (Non-completer = Failure). Data was not collected for any participants due to termination of the study. | ||
| SECONDARY | Number of Participants With Treatment Emergent Cytopenic Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | Analysis was performed in all treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms | After Day 1 to end of treatment; up to Weeks 24 or 48 | Analysis was performed in all treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs) | After Day 1 to end of treatment; up to Weeks 24 or 48 | The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Cells/uL | MEAN |
| SECONDARY | Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Percent change | MEAN |
| SECONDARY | Mean Change in Total Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Cells/µL | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Cohort A: HCV GT-2 or GT-3 | 88 | Participants | ||
| Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Cohort B: HCV GT-1 or GT-4 | 149 | Participants | ||
| Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Cohort A: HCV GT-2 or GT-3 | RVR | 82 | Participants | |
| Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Cohort B: HCV GT-1 or GT-4 | RVR | 149 | Participants | |
| Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Cohort A: HCV GT-2 or GT-3 | eRVR | 80 | Participants | |
| Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Cohort B: HCV GT-1 or GT-4 | eRVR | 138 | Participants | |
| Number of Participants With Treatment Emergent Cytopenic Abnormalities | Cohort A: HCV GT-2 or GT-3 | 4 | Participants | ||
| Number of Participants With Treatment Emergent Cytopenic Abnormalities | Cohort B: HCV GT-1 or GT-4 | 15 | Participants | ||
| Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms | Cohort A: HCV GT-2 or GT-3 | Musculoskeletal symptoms | 6 | Participants | |
| Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms | Cohort B: HCV GT-1 or GT-4 | Musculoskeletal symptoms | 21 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Cohort A: HCV GT-2 or GT-3 | 104 | |
| Treatment Period | STARTED | Cohort B: HCV GT-1 or GT-4 | 196 | |
| Treatment Period | COMPLETED | Cohort A: HCV GT-2 or GT-3 | 95 | |
| Treatment Period | COMPLETED | Cohort B: HCV GT-1 or GT-4 | 161 | |
| Treatment Period | NOT COMPLETED | Cohort A: HCV GT-2 or GT-3 | 9 | |
| Treatment Period | NOT COMPLETED | Cohort B: HCV GT-1 or GT-4 | 35 | |
| Follow-up Period | STARTED | Cohort A: HCV GT-2 or GT-3 | 102 | |
| Follow-up Period | STARTED | Cohort B: HCV GT-1 or GT-4 | 185 | |
| Follow-up Period | COMPLETED | Cohort A: HCV GT-2 or GT-3 | 96 | |
| Follow-up Period | COMPLETED | Cohort B: HCV GT-1 or GT-4 | 176 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aspartate aminotransferase increased | Investigations | Cohort A: HCV GT-2 or GT-3 | 8 | 104 | 10 |
| other | Aspartate aminotransferase increased | Investigations | Cohort B: HCV GT-1 or GT-4 | 4 | 196 | 16 |
| other | Weight decreased | Investigations | Cohort A: HCV GT-2 or GT-3 | 4 | 104 | 5 |
| other | Weight decreased | Investigations | Cohort B: HCV GT-1 or GT-4 | 11 | 196 | 11 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Cohort A: HCV GT-2 or GT-3 | 4 | 104 | 4 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Cohort B: HCV GT-1 or GT-4 | 10 | 196 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A: HCV GT-2 or GT-3 | 7 | 104 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: HCV GT-1 or GT-4 | 16 | 196 | 16 |
| other | Headache | Nervous system disorders | Cohort A: HCV GT-2 or GT-3 | 10 | 104 | 13 |
| other | Headache | Nervous system disorders | Cohort B: HCV GT-1 or GT-4 | 31 | 196 | 39 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: HCV GT-2 or GT-3 | 0 | 104 |
| Total, all-cause mortality | Cohort B: HCV GT-1 or GT-4 | 3 | 196 |
| Total, other adverse events | Cohort A: HCV GT-2 or GT-3 | 70 | 104 |
| Total, other adverse events | Cohort B: HCV GT-1 or GT-4 | 159 | 196 |
| Total, serious adverse events | Cohort A: HCV GT-2 or GT-3 | 6 | 104 |
| Total, serious adverse events | Cohort B: HCV GT-1 or GT-4 | 12 | 196 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28282271 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Trial comparisons |
| Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: Number of Participants With Treatment Emergent Cytopenic Abnormalities | Trial comparisons |
| Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: deaths from any cause | Trial comparisons |
| Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: serious adverse events | Trial comparisons |
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.
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