Trial · NCT01598090
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
NCT01598090, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2019-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir. Trials, record NCT01598090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01598090
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
- NCT number
- NCT01598090
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 881 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis C Virus
- Interventions
- Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin, Telaprevir
- First posted
- 2012-05-15
- Last updated
- 2019-07-31
- Other registries' IDs
- eudract:2011-004695-11
- Results first posted
- 2019-05-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | Assessed at Week 4 and Week 12, week 12 reported | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Primary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Day 1 of treatment up to Week 48 | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. |
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | Follow up week 24 | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. |
| Secondary | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | After Day 1 of treatment up to Week 48 | Cytopenic abnormalities included anemia defined as hemoglobin \<10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) \<750 cubic millimetre (mm\^3); thrombocytopenia defined as platelets \<50,000 mm\^3. |
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | Week 4 and Week 12 | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | After Day 1 of treatment up to Week 48 | Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. |
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | Follow-up Week 24 | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | Assessed at Week 4 and Week 12, week 12 reported | The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Day 1 of treatment up to Week 48 | Safety analysis included all treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | Follow-up Week 12 | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | Follow up week 24 | Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treatment-naive treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | After Day 1 of treatment up to Week 48 | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | Week 4 and Week 12 | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | After Day 1 of treatment up to Week 48 | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | Follow-up Week 24 | Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination. | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 51.9 | 95% Confidence Interval 31.9 to 71.3 | Percentage of participants | |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Part B: Peginterferon Lambda-1a + RBV + TVR | 76.2 | 95% Confidence Interval 72 to 80.3 | Percentage of participants | |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Part B: Peginterferon Alfa-2a + RBV + TVR | 82 | 95% Confidence Interval 76.8 to 87.3 | Percentage of participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | AEs | 26 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | SAEs | 6 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Drug related AEs | 12 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Discontinuation due to AEs | 2 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Death | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Dose reductions - Lambda | 3 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Dose reductions - RBV | 7 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 27 | |
| Treatment Period | STARTED | Part B: Peginterferon Lambda-1a + RBV + TVR | 411 | |
| Treatment Period | STARTED | Part B: Peginterferon Alfa-2a + RBV + TVR | 206 | |
| Treatment Period | COMPLETED | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 16 | |
| Treatment Period | COMPLETED | Part B: Peginterferon Lambda-1a + RBV + TVR | 339 | |
| Treatment Period | COMPLETED | Part B: Peginterferon Alfa-2a + RBV + TVR | 171 | |
| Treatment Period | NOT COMPLETED | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 11 | |
| Treatment Period | NOT COMPLETED | Part B: Peginterferon Lambda-1a + RBV + TVR | 72 | |
| Treatment Period | NOT COMPLETED | Part B: Peginterferon Alfa-2a + RBV + TVR | 35 | |
| Follow-up Period | STARTED | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 26 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events273
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 | Amylase increased | Investigations | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 0 | 27 | 0 |
| other | Amylase increased | Investigations | Part B: Peginterferon Lambda-1a + RBV + TVR | 21 | 411 | 26 |
| other | Amylase increased | Investigations | Part B: Peginterferon Alfa-2a + RBV + TVR | 3 | 206 | 5 |
| other | Blood bilirubin increased | Investigations | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 2 | 27 | 3 |
| other | Blood bilirubin increased | Investigations | Part B: Peginterferon Lambda-1a + RBV + TVR | 19 | 411 | 25 |
| other | Blood bilirubin increased | Investigations | Part B: Peginterferon Alfa-2a + RBV + TVR | 2 | 206 | 2 |
| other | Alanine aminotransferase increased | Investigations | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 2 | 27 | 2 |
| other | Alanine aminotransferase increased | Investigations | Part B: Peginterferon Lambda-1a + RBV + TVR | 30 | 411 | 33 |
| other | Alanine aminotransferase increased | Investigations | Part B: Peginterferon Alfa-2a + RBV + TVR | 1 | 206 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 1 | 27 | 1 |
1 to 10 of 273Source ClinicalTrials.gov
See all 273 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 0 | 27 |
| Total, all-cause mortality | Part B: Peginterferon Lambda-1a + RBV + TVR | 1 | 411 |
| Total, all-cause mortality | Part B: Peginterferon Alfa-2a + RBV + TVR | 1 | 206 |
| Total, other adverse events | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 26 | 27 |
| Total, other adverse events | Part B: Peginterferon Lambda-1a + RBV + TVR | 369 | 411 |
| Total, other adverse events | Part B: Peginterferon Alfa-2a + RBV + TVR | 197 | 206 |
| Total, serious adverse events | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | 6 | 27 |
| Total, serious adverse events | Part B: Peginterferon Lambda-1a + RBV + TVR | 43 | 411 |
| Total, serious adverse events | Part B: Peginterferon Alfa-2a + RBV + TVR | 20 | 206 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23743475 | 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.
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