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

Hepatitis C, Chronic Clinical Trial

— SUPPORT  

Official title:

Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726557
• Other study ID #: P04408
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Substance Abuse, Intravenous

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