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Generated: March 24, 2019

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CLINICAL TRIALS PROFILE FOR BOCEPREVIR

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Clinical Trials for Boceprevir

Trial ID Title Status Sponsor Phase Summary
NCT00160251 Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 2 The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
NCT00423670 Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523) Completed Merck Sharp & Dohme Corp. Phase 2 This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.
NCT00689390 Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063) Terminated Merck Sharp & Dohme Corp. Phase 2/Phase 3 Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants will be followed for up to 3.5 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response (for sustained responders) and to characterize the long-term safety after use of this therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.
NCT00705432 Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone. The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Boceprevir

Condition Name

Condition Name for Boceprevir
Intervention Trials
Hepatitis C 21
Hepatitis C, Chronic 18
Chronic Hepatitis C 10
HIV 5
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Condition MeSH

Condition MeSH for Boceprevir
Intervention Trials
Hepatitis C 58
Hepatitis 50
Hepatitis A 36
Hepatitis C, Chronic 35
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Clinical Trial Locations for Boceprevir

Trials by Country

Trials by Country for Boceprevir
Location Trials
United States 50
Spain 10
Canada 6
Italy 5
Netherlands 4
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Trials by US State

Trials by US State for Boceprevir
Location Trials
Maryland 8
Texas 5
New York 4
Virginia 3
California 3
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Clinical Trial Progress for Boceprevir

Clinical Trial Phase

Clinical Trial Phase for Boceprevir
Clinical Trial Phase Trials
Phase 4 10
Phase 3 21
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Boceprevir
Clinical Trial Phase Trials
Completed 41
Unknown status 9
Terminated 7
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Clinical Trial Sponsors for Boceprevir

Sponsor Name

Sponsor Name for Boceprevir
Sponsor Trials
Merck Sharp & Dohme Corp. 32
National Institute of Allergy and Infectious Diseases (NIAID) 6
Hoffmann-La Roche 3
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Sponsor Type

Sponsor Type for Boceprevir
Sponsor Trials
Other 102
Industry 45
NIH 7
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