Post-Marketing Surveillance Study of ex-Intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (Study P04408) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00726557

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 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)

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Quality Assurance of HCV-Therapy With PegIntron® Plus Rebetol® in Drug-Substituted Patients - SUPPORT Project Post-Marketing Surveillance Study

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	270
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
All patients 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 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

Groups/Cohorts

Assigned Interventions

All patients

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

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

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 100 sites in Germany.

Criteria

Inclusion Criteria:

Treatment-naïve patients or relapsers to interferon monotherapy
Patients 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 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 subjects must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment

Exclusion Criteria:

Any contraindications specified in the SPC 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 patients with chronic renal failure or creatinine clearance <50 mL/min
Coinfection with HIV
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

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04408
Study First Received:	July 30, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00726557
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Disorders of Environmental Origin
Hepatitis
Virus Diseases

Digestive System Diseases
Mental Disorders
Peginterferon alfa-2b
Substance-Related Disorders
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic
Substance Abuse, Intravenous

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009