Trial · NCT00689390
Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)
NCT00689390, Phase 2, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2015-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063). Trials, record NCT00689390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689390
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)
- NCT number
- NCT00689390
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,954 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Interventions
- Boceprevir, Narlaprevir, Peginterferon alfa-2b, Ribavirin, Blood/Plasma Collection
- First posted
- 2008-06-03
- Last updated
- 2018-09-11
- Other registries' IDs
- eudract:2006-006529-25
- Results first posted
- 2015-10-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) | Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU. |
| Primary | Kaplan-Meier Exposure-adjusted Relapse Rate | From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) | The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = \[(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)\] / 365.25 days \[for 1 year\]. |
| Primary | Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years) | Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS). |
| Primary | Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) | Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. |
| Primary | Number of Participants That Discontinued the LTFU Due to SAEs | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) | An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. |
Source ClinicalTrials.gov
Outcomes5
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 Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) | All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis. | participants | NUMBER |
| PRIMARY | Kaplan-Meier Exposure-adjusted Relapse Rate | From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) | All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis. | relapses per 1,000 person-years | NUMBER |
| PRIMARY | Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years) | All participants with TE-RAVs who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies (i.e. none of the participants in the narlaprevir study had a TE-RAV). | participants | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) | All enrolled participants were included in safety analyses. | participants | NUMBER |
| PRIMARY | Number of Participants That Discontinued the LTFU Due to SAEs | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) | All enrolled participants were included in safety analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
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 Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | Previous SVR on Boceprevir + PR | 8 | participants | ||
| Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | Previous SVR on Narlaprevir + PR | 0 | participants | ||
| Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | Previous SVR on PR Only | 1 | participants | ||
| Kaplan-Meier Exposure-adjusted Relapse Rate | Previous SVR on Boceprevir + PR | 2.3 | relapses per 1,000 person-years | ||
| Kaplan-Meier Exposure-adjusted Relapse Rate | Previous SVR on Narlaprevir + PR | 0 | relapses per 1,000 person-years | ||
| Kaplan-Meier Exposure-adjusted Relapse Rate | Previous SVR on PR Only | 2.2 | relapses per 1,000 person-years | ||
| Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | Participants From Boceprevir Studies With TE-RAVs | V36A TE-RAVs detected | 6 | participants | |
| Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | Participants From Boceprevir Studies With TE-RAVs | __V36A TE-RAVs returned to WT (out of 6) | 6 | participants | |
| Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | Participants From Boceprevir Studies With TE-RAVs | V36G TE-RAVs detected | 1 | participants | |
| Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | Participants From Boceprevir Studies With TE-RAVs | __V36G TE-RAVs returned to WT (out of 1) | 1 | participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants From Boceprevir Studies | 1,907 | |
| Overall Study | STARTED | Participants From Narlaprevir Studies | 47 | |
| Overall Study | COMPLETED | Participants From Boceprevir Studies | 1,481 | |
| Overall Study | COMPLETED | Participants From Narlaprevir Studies | 37 | |
| Overall Study | NOT COMPLETED | Participants From Boceprevir Studies | 426 | |
| Overall Study | NOT COMPLETED | Participants From Narlaprevir Studies | 10 |
Source ClinicalTrials.gov
Adverse events282
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 |
|---|---|---|---|---|---|---|
| serious | ACUTE CORONARY SYNDROME | Cardiac disorders | Participants From Boceprevir Studies | 1 | 1,907 | 1 |
| serious | ACUTE CORONARY SYNDROME | Cardiac disorders | Participants From Narlaprevir Studies | 0 | 47 | 0 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Participants From Boceprevir Studies | 1 | 1,907 | 1 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Participants From Narlaprevir Studies | 0 | 47 | 0 |
| serious | ANGINA UNSTABLE | Cardiac disorders | Participants From Boceprevir Studies | 1 | 1,907 | 1 |
| serious | ANGINA UNSTABLE | Cardiac disorders | Participants From Narlaprevir Studies | 0 | 47 | 0 |
| serious | ATRIAL FIBRILLATION | Cardiac disorders | Participants From Boceprevir Studies | 3 | 1,907 | 3 |
| serious | ATRIAL FIBRILLATION | Cardiac disorders | Participants From Narlaprevir Studies | 0 | 47 | 0 |
| serious | CARDIAC ARREST | Cardiac disorders | Participants From Boceprevir Studies | 2 | 1,907 | 2 |
| serious | CARDIAC ARREST | Cardiac disorders | Participants From Narlaprevir Studies | 0 | 47 | 0 |
1 to 10 of 282Source ClinicalTrials.gov
See all 282 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants From Boceprevir Studies | ||
| Total, all-cause mortality | Participants From Narlaprevir Studies | ||
| Total, other adverse events | Participants From Boceprevir Studies | 0 | 0 |
| Total, other adverse events | Participants From Narlaprevir Studies | 0 | 0 |
| Total, serious adverse events | Participants From Boceprevir Studies | 136 | 1,907 |
| Total, serious adverse events | Participants From Narlaprevir Studies | 2 | 47 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Participants From Boceprevir Studies vs Participants From Narlaprevir Studies: Number of Participants That Discontinued the LTFU Due to SAEs | Trial comparisons |
| Participants From Boceprevir Studies vs Participants From Narlaprevir Studies: Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU | Trial comparisons |
| Participants From Boceprevir Studies vs Participants From Narlaprevir Studies: 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.
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/NCT00689390
GET https://conductscience.org/api/trials/v1/NCT00689390/results?page=2