Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)

NCT ID: NCT00727311

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-06-30

Brief Summary

The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.

Conditions

Hepatitis C, Chronic; Hepatitis C

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PegIntron + Rebetol

Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy

PegIntron (peginterferon alfa-2b; SCH 54031) injector

Intervention Type: BIOLOGICAL

PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) injector

PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling

Intervention Type: BIOLOGICAL

Rebetol (ribavirin; SCH 18908)

Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling

Intervention Type: DRUG

Other Intervention Names

SCH 54031; SCH 18908

Eligibility Criteria

Inclusion Criteria

• Participants with chronic hepatitis C
• At least 18 years old
• Treatment-naïve or relapse to interferon monotherapy
• Platelets >= 100,000/mm^3
• Neutrophil counts >= 1,500/ mm^3
• Thyroid Stimulating Hormone (TSH) must be within normal limits
• Hemoglobin >= 12 gr/dl (females); >= 13 gr/dl (males)
• Intravenous drug abusers (Ex-IVDA) participants being under stable substitution for at least 6 months
• Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment
• Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment

Exclusion Criteria

• Contraindications as per the SPC and approved European labeling
• Hypersensitivity to the active substance or to any inteferons or to any of the excipients
• Pregnant woman
• Woman who are breast-feeding
• Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
• Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance < 50 mL/min
• Autoimmune hepatitis or history of autoimmune disease
• Severe hepatic dysfunction or decompensated cirrhosis of the liver
• Pre-existing thyroid disease unless it can be controlled with conventional therapy
• Epilepsy and/or compromised central nervous system function

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04538

Identifier Type: -

Identifier Source: org_study_id