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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00726557
First received: July 30, 2008
Last updated: December 3, 2013
Last verified: December 2013

July 30, 2008
December 3, 2013
October 2005
January 2009   (final data collection date for primary outcome measure)
  • 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.
  • Providing feasibility data for a HCV therapy with PegIntron 1.5 μg/kg/week and Rebetol (10.6 mg/kg/day) in drug-substituted patients in substitution centers under routine conditions [ Time Frame: During the course of the study ] [ Designated as safety issue: No ]
  • Tolerability of the treatment will be measured by proportion of complete treatment [ Time Frame: Assessed at the end of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00726557 on ClinicalTrials.gov Archive Site
Not Provided
  • Safety of the treatment will be determined by assessment of the incidence rates of serious adverse events and adverse events. [ Time Frame: Reported between the signing of the informed consent and up to 30 days after study completion or discontinuation. ] [ Designated as safety issue: Yes ]
  • Showing better and more effective feasibility of HCV treatment of patients substituted with Subutex in comparison to patients with other drug substitution pharmacotherapies like e.g. methadone (determination of SVR) [ Time Frame: At the end of treatment ] [ Designated as safety issue: No ]
  • Assessment of efficacy by measuring the rate of HCV-RNA negativity 24 weeks post treatment. [ Time Frame: Assessed at 24 weeks post-treatment. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Hepatitis C, Chronic
  • Substance Abuse, Intravenous
  • 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
PegIntron + Rebetol
There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).
Interventions:
  • Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)
  • Drug: Rebetol (ribavirin; SCH 18908)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00726557
P04408
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP