Trial · NCT00705432
Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
NCT00705432, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-06-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED). Trials, record NCT00705432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705432
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
- NCT number
- NCT00705432
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,472 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Chronic
- Interventions
- Peginterferon alfa-2b (PEG), Ribavirin (RBV), Placebo, Boceprevir
- First posted
- 2008-06-26
- Last updated
- 2017-04-07
- Other registries' IDs
- eudract:2007-005508-42
- Results first posted
- 2011-06-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Virologic Response (SVR) Rate | At Follow-up Week (FW) 24 | Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR. |
| Secondary | Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo) | At FW 24 | Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR. |
| Secondary | Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization. | At FW 12 and at 72 weeks after randomization | Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL. |
| Secondary | Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20) | At Treatment Week 2, 4, 8, 12, 16, or 20 | Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL. |
| Secondary | Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR | At Treatment Week 4, 8, 12, 16, 20 | Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL. |
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 | Sustained Virologic Response (SVR) Rate | At Follow-up Week (FW) 24 | Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir). | Percentage of participants | NUMBER |
| SECONDARY | Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo) | At FW 24 | Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization. | At FW 12 and at 72 weeks after randomization | Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir). | Participants | NUMBER |
| SECONDARY | Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20) | At Treatment Week 2, 4, 8, 12, 16, or 20 | Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir). | Participants | NUMBER |
| SECONDARY | Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR | At Treatment Week 4, 8, 12, 16, 20 | Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Virologic Response (SVR) Rate | Cohort I - 1. Placebo + PEG + RBV | 40.2 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate | Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | 66.8 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate | Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks | 68.5 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate | Cohort II - 1. Placebo + PEG + RBV | 23.1 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate | Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | 42.3 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate | Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks | 52.7 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo) | Cohort I - 1. Placebo + PEG + RBV | 42.1 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo) | Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | 69.6 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo) | Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks | 71.2 | Percentage of participants | ||
| Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo) | Cohort II - 1. Placebo + PEG + RBV | 25.5 | Percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Cohort I - 1. Placebo + PEG + RBV | 311 | |
| Treatment Period | STARTED | Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | 316 | |
| Treatment Period | STARTED | Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks | 311 | |
| Treatment Period | STARTED | Cohort II - 1. Placebo + PEG + RBV | 52 | |
| Treatment Period | STARTED | Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | 52 | |
| Treatment Period | STARTED | Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks | 55 | |
| Treatment Period | STARTED BOCEPREVIR/PLACEBO | Cohort I - 1. Placebo + PEG + RBV | 297 | |
| Treatment Period | STARTED BOCEPREVIR/PLACEBO | Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | 303 | |
| Treatment Period | STARTED BOCEPREVIR/PLACEBO | Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks | 299 | |
| Treatment Period | STARTED BOCEPREVIR/PLACEBO | Cohort II - 1. Placebo + PEG + RBV | 47 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events564
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 | ANAEMIA | Blood and lymphatic system disorders | PEG + RBV | 107 | 363 | 188 |
| other | ANAEMIA | Blood and lymphatic system disorders | BOCEPREVIR + PEG + RBV - 24 WEEKS | 182 | 368 | 292 |
| other | ANAEMIA | Blood and lymphatic system disorders | BOCEPRIVIR + PEG + RBV - 44 WEEKS | 179 | 366 | 352 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | PEG + RBV | 33 | 363 | 81 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | BOCEPREVIR + PEG + RBV - 24 WEEKS | 31 | 368 | 83 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | BOCEPRIVIR + PEG + RBV - 44 WEEKS | 45 | 366 | 126 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | PEG + RBV | 77 | 363 | 208 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | BOCEPREVIR + PEG + RBV - 24 WEEKS | 91 | 368 | 216 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | BOCEPRIVIR + PEG + RBV - 44 WEEKS | 93 | 366 | 257 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | PEG + RBV | 7 | 363 | 16 |
1 to 10 of 564Source ClinicalTrials.gov
See all 564 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG + RBV | ||
| Total, all-cause mortality | BOCEPREVIR + PEG + RBV - 24 WEEKS | ||
| Total, all-cause mortality | BOCEPRIVIR + PEG + RBV - 44 WEEKS | ||
| Total, other adverse events | PEG + RBV | 353 | 363 |
| Total, other adverse events | BOCEPREVIR + PEG + RBV - 24 WEEKS | 365 | 368 |
| Total, other adverse events | BOCEPRIVIR + PEG + RBV - 44 WEEKS | 363 | 366 |
| Total, serious adverse events | PEG + RBV | 31 | 363 |
| Total, serious adverse events | BOCEPREVIR + PEG + RBV - 24 WEEKS | 42 | 368 |
| Total, serious adverse events | BOCEPRIVIR + PEG + RBV - 44 WEEKS | 45 | 366 |
Source ClinicalTrials.gov
Papers3
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 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/NCT00705432
GET https://conductscience.org/api/trials/v1/NCT00705432/results?page=2