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Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (Study P04408)(COMPLETED) (SUPPORT)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00726557
First received: July 30, 2008
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis C, Chronic
Substance Abuse, Intravenous
 Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)
Drug: Rebetol (ribavirin; SCH 18908)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 [ Time Frame: End of Follow-up (Week 48 or Week 72, depending on genotype) ] [ Designated as safety issue: No ]
    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/Week [ Time Frame: Assessed at the end of treatment ] [ Designated as safety issue: No ]
    Tolerability of the treatment was measured by number of participants with complete treatment.


Enrollment: 246
Study Start Date: October 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
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
Other Name: SCH 54031
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
Other Name: SCH 18908

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00726557     History of Changes
Other Study ID Numbers: P04408
Study First Received: July 30, 2008
Results First Received: April 15, 2010
Last Updated: June 9, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Substance Abuse, Intravenous
Hepatitis C, Chronic
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Mental Disorders
 Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013