Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243) - Full Text View

Purpose

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with HCV genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

Condition	Intervention
Hepatitis C, Chronic	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)

MedlinePlus related topics:

Hepatitis Hepatitis C

Drug Information available for:

Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	A Non-Interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Rates of virologic response at Treatment Weeks 12, 24, 48 and sustained virologic response (SVR), assessed based on the level of fibrosis: minimal fibrosis (METAVIR score F0/F1) vs well-established fibrosis (METAVIR score F2/F3/F4). [ Time Frame: Assessed at Treatment Weeks 12, 24, and 48. SVR assessed at 24 weeks post-treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virologic response in different subgroups (eg, low versus high viral load, F4 versus F2/F3 versus F0/F1); identifying parameters associated with virologic response. [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	December 2004
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1 Previously untreated patients infected with HCV genotype 1, 4, 5, or 6 at approximately 60 sites in Belgium.	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks Drug: Rebetol (ribavirin; SCH 18908) Rebetol administered based on body weight 800-1200 mg/day (<65 kg: 800 mg; 65 - 85 kg: 1000 mg; >85 kg: 1200 mg) orally for 48 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Previously untreated patients with chronic hepatitis C, infected with HCV genotype 1, 4, 5, or 6, receiving treatment with PegIntron and Rebetol at approximately 60 sites in Belgium.

Criteria

Inclusion Criteria:

Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
Detectable HCV-RNA in serum by PCR
Repeated (with at least a 1 month interval) serum transaminase (ALT) levels above the upper normal limit for gender
Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4

Exclusion Criteria:

Known hypersensitivity for any active ingredient or constituent
Pregnancy or lactation
Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance <50 mL/minute
Hepatitis of immunologic origin or medically documented history of auto-immune disease
Severe hepatic disorder or decompensated cirrhosis
Pre-existing thyroid disorder, except if under control with classical treatment
Epilepsy or central nervous system disorder
Hemoglobin pathology, eg, thalassaemia, sickle cell anemia

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04243
First Received:	June 23, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00709059
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Schering-Plough:

hepatitis C

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Hepatic fibrosis

Digestive System Diseases

Hepatitis, Chronic

Fibrosis

Ribavirin

Peginterferon alfa-2b

Hepatitis, Viral, Human

Hepatitis C

Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00709059