Study of Patients With Chronic Hepatitis C Infected With HCV LVL 1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793AM2) - Full Text View

Purpose

To determine the relapse rate at 24 weeks follow up in HCV LVL G1 patients treated for 24 weeks with Peg Intron and Rebetol who are HCV-RNA negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

Condition	Intervention
Hepatitis C	Drug: Peg-Intron Drug: Rebetol

MedlinePlus related topics:

Hepatitis Hepatitis C

Drug Information available for:

Ribavirin Interferon alfa-2b Interferons Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With HCV Genotype 1 Low Viral Load (HCV LVL 1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Relapse rate in HCV LVL G1 patients [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients (%) with sustained virological response [ Time Frame: 24 weeks post treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood sample for PCR

Enrollment:	172
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 Those with chronic Hepatitis C infected with HCV LVL 1	Drug: Peg-Intron 1.5 ug/kg/week Drug: Rebetol 800-1200 mg/day

Detailed Description:

Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

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

primary care clinic

Criteria

Inclusion Criteria:

Willingness to participate
18 years or older, either gender, any race
Must have HCV LVL (positive, but <600,000 IU/mL on the assay used by the individual study site. Only HCV-RNA/qPCR assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
Subject considered suitable for treatment per local label
Investigator considers suitable and subject consents to be treated

Exclusion Criteria:

Does not show negative PCR at week 4
Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the SmPC

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04793
First Received:	June 23, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00709228
Health Authority:	Greece: Ethics Committee

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Interferons

Ribavirin

Peginterferon alfa-2b

Hepatitis, Viral, Human

Hepatitis C

Interferon Alfa-2b

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:	NCT00709228