Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
- Conditions
- Hepatitis C, ChronicSubstance Abuse, Intravenous
- Interventions
- Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)Drug: Rebetol (ribavirin; SCH 18908)
- Registration Number
- NCT00726557
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
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Treatment-naïve participants or relapsers to interferon monotherapy
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Participants with chronic hepatitis C infection
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At least 18 years of age
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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
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Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
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Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PegIntron + Rebetol PegIntron (pegylated interferon alfa-2b; SCH 54031) There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters). PegIntron + Rebetol Rebetol (ribavirin; SCH 18908) There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).
- Primary Outcome Measures
Name Time Method Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions End of Follow-up (Week 48 or Week 72, depending on genotype) Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).
Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week Assessed at the end of treatment Tolerability of the treatment was measured by number of participants with complete treatment.
- Secondary Outcome Measures
Name Time Method