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

NCT00726557 | Completed Results

• 1 other identifier: P04408
• Study Type: observational
• Target: 246
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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

Study Arms (1)

PegIntron + Rebetol

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

Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

Interventions

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

Also known as: SCH 54031

PegIntron + Rebetol

Rebetol (ribavirin; SCH 18908) 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

Also known as: SCH 18908

PegIntron + Rebetol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previous intravenous drug abusers with chronic hepatitis C receiving substitution therapy (buprenorphine, methadone or other) at approximately 100 sites in Germany.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Substance Abuse, Intravenous

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: October 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 9, 2015
• Results First Posted: May 17, 2010

Record last verified: 2015-10