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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00726557
Other study ID # P04408
Secondary ID
Status Completed
Phase N/A
First received July 30, 2008
Last updated October 8, 2015
Start date October 2005
Est. completion date January 2009

Study information

Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 246
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Biological:
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
Drug:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). End of Follow-up (Week 48 or Week 72, depending on genotype) No
Primary Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week Tolerability of the treatment was measured by number of participants with complete treatment. Assessed at the end of treatment No
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