- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00709228
Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)
January 14, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Detailed Description
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
Study Type
Observational
Enrollment (Actual)
496
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
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]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PegIntron plus Rebetol
Those with chronic Hepatitis C infected with HCV LVL G1
|
1.5 ug/kg/week
Other Names:
800-1200 mg/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 24 of follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
June 23, 2008
First Submitted That Met QC Criteria
July 2, 2008
First Posted (ESTIMATE)
July 3, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 14, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
- Peginterferon alfa-2b
Other Study ID Numbers
- P04793
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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