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

Completed
Conditions
Hepatitis C, Chronic
Substance 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
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

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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PegIntron + RebetolPegIntron (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 + RebetolRebetol (ribavirin; SCH 18908)There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).
Primary Outcome Measures
NameTimeMethod
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 ConditionsEnd 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/WeekAssessed at the end of treatment

Tolerability of the treatment was measured by number of participants with complete treatment.

Secondary Outcome Measures
NameTimeMethod
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