Trial · NCT00423670
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
NCT00423670, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2011-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523). Trials, record NCT00423670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423670
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
- NCT number
- NCT00423670
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 765 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Hepatitis C
- Interventions
- boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron), ribavirin, ribavirin (low-dose)
- First posted
- 2007-01-18
- Last updated
- 2017-04-05
- Other registries' IDs
- eudract:2006-002543-92
- Results first posted
- 2011-06-15
Source ClinicalTrials.gov
Registered outcomes8
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 (SVR) | From follow-up week (FW) 24 up to end of follow-up (EOF) | Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL). A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR. |
| Secondary | Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin | From FW 24 up to EOF | Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL. |
| Secondary | Number of Participants With SVR Based on Duration of Boceprevir Treatment | From FW 24 up to EOF | Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL. |
| Secondary | Number of Participants Negative for HCV-RNA at FW 12 | At FW 12 | Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL. |
| Secondary | Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization | 72 weeks post randomization | Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL. |
| Secondary | Number of Participants With an Early Virologic Response (EVR) That Achieved SVR | At TW 12, and at FW 24 up to EOF | Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. if he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL. |
| Secondary | Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR | At FW 12 and FW 24 up to EOF | Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. if he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL. |
| Secondary | Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR | At FW 24 up to EOF and at 72 weeks post randomization | Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. if he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL. |
Source ClinicalTrials.gov
Outcomes8
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 (SVR) | From follow-up week (FW) 24 up to end of follow-up (EOF) | Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir). | Participants | NUMBER |
| SECONDARY | Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin | From FW 24 up to EOF | Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir). | Participants | NUMBER |
| SECONDARY | Number of Participants With SVR Based on Duration of Boceprevir Treatment | From FW 24 up to EOF | Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir). | Participants | NUMBER |
| SECONDARY | Number of Participants Negative for HCV-RNA at FW 12 | At FW 12 | Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir). | Participants | NUMBER |
| SECONDARY | Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization | 72 weeks post randomization | Participants | NUMBER | |
| SECONDARY | Number of Participants With an Early Virologic Response (EVR) That Achieved SVR | At TW 12, and at FW 24 up to EOF | Participants with an early virologic response (EVR). | Participants | NUMBER |
| SECONDARY | Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR | At FW 12 and FW 24 up to EOF | Participants with undetectable HCV-RNA at FW 12. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR | At FW 24 up to EOF and at 72 weeks post randomization | Participants who achieved SVR. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group88
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 (SVR) | Arm 1. PEG +RBV for 48 Wks (Part I) | 39 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | Arm 2. PEG + RBV + BOC for 28 Wks (Part I) | 58 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I) | 58 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | Arm 4. PEG +RBV + BOC for 48 Wks (Part I) | 69 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I) | 77 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | Arm 6. PEG + RBV + BOC for 48 Wks (Part II) | 8 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II) | 21 | Participants | ||
| Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin | Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4) | 135 | Participants | ||
| Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin | Arm 2 and Arm 4. PEG + RBV + BOC | 127 | Participants | ||
| Number of Participants With SVR Based on Duration of Boceprevir Treatment | Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks) | 146 | Participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Arm 1. PEG +RBV for 48 Wks (Part I) | 104 | |
| Treatment Period | STARTED | Arm 2. PEG + RBV + BOC for 28 Wks (Part I) | 107 | |
| Treatment Period | STARTED | Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I) | 103 | |
| Treatment Period | STARTED | Arm 4. PEG +RBV + BOC for 48 Wks (Part I) | 103 | |
| Treatment Period | STARTED | Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I) | 103 | |
| Treatment Period | STARTED | Arm 6. PEG + RBV + BOC for 48 Wks (Part II) | 16 | |
| Treatment Period | STARTED | Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II) | 59 | |
| Treatment Period | STARTED | Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I) | 36 | |
| Treatment Period | COMPLETED | Arm 1. PEG +RBV for 48 Wks (Part I) | 52 | |
| Treatment Period | COMPLETED | Arm 2. PEG + RBV + BOC for 28 Wks (Part I) | 77 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,680
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 for 48 Wks (Part I) | 35 | 104 | 55 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG + RBV + BOC for 28 Wks (Part I) | 59 | 107 | 96 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I) | 55 | 103 | 80 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG +RBV + BOC for 48 Wks (Part I) | 54 | 103 | 79 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I) | 58 | 103 | 88 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG + RBV + BOC for 48 Wks (Part II) | 10 | 16 | 22 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG +Low-dose RBV + BOC for 48 Wks (Part II) | 14 | 59 | 39 |
| other | ANAEMIA | Blood and lymphatic system disorders | PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I) | 13 | 36 | 13 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | PEG +RBV for 48 Wks (Part I) | 6 | 104 | 15 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | PEG + RBV + BOC for 28 Wks (Part I) | 7 | 107 | 37 |
1 to 10 of 1,680Source ClinicalTrials.gov
See all 1,680 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG +RBV for 48 Wks (Part I) | ||
| Total, all-cause mortality | PEG + RBV + BOC for 28 Wks (Part I) | ||
| Total, all-cause mortality | PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I) | ||
| Total, all-cause mortality | PEG +RBV + BOC for 48 Wks (Part I) | ||
| Total, all-cause mortality | PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I) | ||
| Total, all-cause mortality | PEG + RBV + BOC for 48 Wks (Part II) | ||
| Total, all-cause mortality | PEG +Low-dose RBV + BOC for 48 Wks (Part II) | ||
| Total, all-cause mortality | PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I) | ||
| Total, other adverse events | PEG +RBV for 48 Wks (Part I) | 102 | 104 |
| Total, other adverse events | PEG + RBV + BOC for 28 Wks (Part I) | 106 | 107 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20692693 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4) vs Arm 2 and Arm 4. PEG + RBV + BOC: Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin | Trial comparisons |
| Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks) vs Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks): Number of Participants With SVR Based on Duration of Boceprevir Treatment | 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/NCT00423670
GET https://conductscience.org/api/trials/v1/NCT00423670/results?page=2