Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793AM2)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00709228

First received: June 23, 2008

Last updated: February 24, 2010

Last verified: February 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2008
Last Updated Date	February 24, 2010
Start Date ^ICMJE	May 2006
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2010)	Number of HCV LVL G1 Participants Who Relapsed [ Time Frame: Week 24 of follow-up ] [ Designated as safety issue: No ] Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.
Original Primary Outcome Measures ^ICMJE (submitted: July 2, 2008)	Relapse rate in HCV LVL G1 patients [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00709228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: July 2, 2008)	Proportion of patients (%) with sustained virological response [ Time Frame: 24 weeks post treatment ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793AM2)(COMPLETED)
Official Title ^ICMJE	PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) 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
Brief Summary	To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (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.
Detailed Description	Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Blood sample for PCR
Sampling Method	Non-Probability Sample
Study Population	primary care clinic
Condition ^ICMJE	Hepatitis C
Intervention ^ICMJE	Drug: PegIntron 1.5 ug/kg/week Other Name: SCH 054031 Drug: Rebetol 800-1200 mg/day Other Name: SCH 18908
Study Group/Cohort (s)	PegIntron plus Rebetol Those with chronic Hepatitis C infected with HCV LVL G1 Interventions: Drug: PegIntron Drug: Rebetol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	496
Completion Date	November 2008
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Willingness to participate 18 years or older, either gender, any race Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [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 polymerase chain reaction [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 Summary of Product Characteristics [SmPC]
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00709228
Other Study ID Numbers ^ICMJE	P04793
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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