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Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)

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ClinicalTrials.gov Identifier: NCT00709228
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : February 22, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment
Hepatitis C Drug: PegIntron Drug: Rebetol

Detailed Description:
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
Study Design
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Study Type : Observational
Actual Enrollment : 496 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
PegIntron plus Rebetol
Those with chronic Hepatitis C infected with HCV LVL G1
 Drug: PegIntron
1.5 ug/kg/week
Other Name: SCH 054031

Drug: Rebetol
800-1200 mg/day
Other Name: SCH 18908


Outcome Measures
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Primary Outcome Measures :
  1. Number of HCV LVL G1 Participants Who Relapsed [ Time Frame: Week 24 of follow-up ]
    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.


Biospecimen Retention:   Samples With DNA
Blood sample for PCR

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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]
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00709228    
Other Study ID Numbers: P04793
First Posted: July 3, 2008    Key Record Dates
Results First Posted: February 22, 2010
Last Update Posted: January 26, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents