A Single-Arm Study to Provide Boceprevir Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies. - Provide

• Conditions: Chronic Hepatitis C; MedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2008-004556-71-DE
• Lead Sponsor: Schering-Plough Research Institute, A Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

1. Subject must have been assigned to a peginterferon/RBV control arm in a previous SPRI study of boceprevir, must have completed treatment as per protocol, and have been compliant with all study treatment and scheduled procedures within the previous study

2. Subject must have received at least 12 weeks of treatment with peginterferon/RBV and must have discontinued treatment in the previous study due to the futility rule (as defined in the previous protocol), had virologic breakthrough, or relapse

3. Subject must have had detectable HCV-RNA upon completion of the previous study

4. Subject and subject’s partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs, or longer if dictated by local regulations

5. Subject must be willing to give written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. All subject exclusion criteria from the SPRI clinical study in which the subject participated prior to qualifying for this study will apply in this study, EXCEPT for the following:
a. Treatment with ribavirin within 90 days and any interferon-alpha within1 month of the enrollment is not exclusionary in P05514
b. Participation in any other SPRI clinical trial within 30 days of enrollment in this study is not exclusionary
c. Use of growth factor at the entry of the study is allowed if it was prescribed in the previous study
d. Laboratory criteria of thyroid-stimulating hormone (TSH) do not apply. Laboratory criteria of hemoglobin, neutrophis, and platelets do not apply, unless they met dose reduction/interruption/discontinuation criteria in the previous study
e. Subjects who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded

2. Subjects had the opportunity to receive boceprevir in the previous study

3. Subjects requiring discontinuation, interruption, or dose reduction of ribavirin for more than 2 weeks in the previous study

4. Subjects requiring discontinuation, interruption, or dose reduction of peginterferon alfa to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study

5. Subjects who experienced a life-threatening SAE considered at least possibly related to study drugs by the investigator or sponsor in the previous study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified