Status:
COMPLETED
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Substance Abuse, Intravenous
Eligibility:
All Genders
18+ years
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00726557
Start Date
October 1 2005
End Date
January 1 2009
Last Update
October 9 2015
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