Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)

NCT ID: NCT00726557

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-01-31

Brief Summary

Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.

Conditions

Hepatitis C, Chronic; Substance Abuse, Intravenous

Study Design

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

Study Groups

PegIntron + Rebetol

There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).

PegIntron (pegylated interferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

Interventions

PegIntron (pegylated interferon alfa-2b; SCH 54031)

PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

Intervention Type: BIOLOGICAL

Rebetol (ribavirin; SCH 18908)

Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

Intervention Type: DRUG

Other Intervention Names

SCH 54031; SCH 18908

Eligibility Criteria

Inclusion Criteria

• Treatment-naïve participants or relapsers to interferon monotherapy
• Participants with chronic hepatitis C infection
• At least 18 years of age
• Must meet the following laboratory criteria:

• Platelets >=100,000/mm^3
• Neutrophil count >=1,500/mm^3
• TSH (thyroid stimulating hormone) within normal limits
• Hemoglobin >=12 g/dL (females); >=13 g/dL (males)
• Ex-intravenous drug abusers who are under stable substitution therapy
• Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
• Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment

Exclusion Criteria

• Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling
• Hypersensitivity to the active substance or to any interferons or to any of the excipients
• Pregnant women
• Women 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 6 months
• Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance <50 mL/min
• Coinfection with HIV (Human Immunodeficiency Virus)
• 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

P04408

Identifier Type: -

Identifier Source: org_study_id