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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00709228

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 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
Study First Received:	June 23, 2008
Last Updated:	December 14, 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
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 January 14, 2009