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Comparison · NCT00423670-d8d18217

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

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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, record NCT00423670-d8d18217. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00423670-d8d18217

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7090.6430.767wilson
Risk in group 20.5520.4850.618wilson
Risk difference, group 1 minus group 20.1560.06360.245newcombe hybrid score
Risk ratio, group 1 over group 21.281.11.49log
Odds ratio, group 1 over group 21.971.312.96log
Number needed to treat, for one more participant with the outcome on Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks) than on Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)6.44.0815.7from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.146206OG000
Group 2Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.116210OG001

Outcome

Type
SECONDARY
Title
Number of Participants With SVR Based on Duration of Boceprevir Treatment
Description
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.
Time frame
From FW 24 up to EOF
Population
Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).

Source ClinicalTrials.gov

Trial

Title
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
NCT number
NCT00423670
Phases
PHASE2
Conditions
Chronic Hepatitis C
Interventions
boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron), ribavirin, ribavirin (low-dose)
Lead sponsor
Merck Sharp & Dohme LLC
Results first posted
2011-06-15

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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