Long-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006529-25-FR

Enrollment

700

Registered

2007-01-12

Start date

2007-02-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term Follow-up of prior study participants MedDRA version: 8.1 Level: LLT Classification code 10019641 Term: Hepatic cirrhosis

Interventions

Product Code: SCH 503034 Pharmaceutical Form: Capsule* Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject must be willing to give written informed consent and be able to adhere to the visit schedule. - Subjects must have received at least one dose of SCH 503034 plus peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous SPRI Phase 2 or 3 clinical study in which SCH 503034 was administered. 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

Exclusion criteria: - Concurrent participation in any other clinical study for the treatment of chronic hepatitis C. - Retreatment with any anitviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuatio from, the SPRI Phase 2 or 3 clinical study in which the subject previously participated/ - Any condition which on the opinion of the Investigtaor would make the subject unsuitable for enrollment.

Design outcomes

Primary

Measure	Time frame
Main Objective: Confirm the durability of the virologic response in subjects with chronic hepatitis C who were sustained responders 24 weeks post-treatment in the previous study. Characterize the long-term safety in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study. ?Characterize the natural history of HCV sequence variants in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study.;Secondary Objective: ; Primary end point(s): The primary endpoint in this study is the durability of virologic response in subjects with chronic hepatitis C who were sustained responders at 24 weeks post-treatment in the previous study. A subject is classified as a sustained responder at a given timepoint is HCV-RNA is below the lower limit of detection at that timepoint. In addition, the study will also charatcterize the following: - The long-term safety in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study. ?The natural history of HCV sequence variants in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study.	—

Measure

Time frame

Main Objective: Confirm the durability of the virologic response in subjects with chronic hepatitis C who were sustained responders 24 weeks post-treatment in the previous study. Characterize the long-term safety in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study. ?Characterize the natural history of HCV sequence variants in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study.;Secondary Objective: ; Primary end point(s): The primary endpoint in this study is the durability of virologic response in subjects with chronic hepatitis C who were sustained responders at 24 weeks post-treatment in the previous study. A subject is classified as a sustained responder at a given timepoint is HCV-RNA is below the lower limit of detection at that timepoint. In addition, the study will also charatcterize the following: - The long-term safety in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study. ?The natural history of HCV sequence variants in subjects who were treated with SCH 503034 and peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous Phase 2 or 3 clinical study.

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Countries

France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026