Status:
COMPLETED
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
Brief Summary
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will als...
Eligibility Criteria
Inclusion
- Willing to participate in the study and sign the Informed Consent Form
- Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction \[PCR\] test)
- Can be treatment-naïve, have retreatment, or co-infected with HIV
- Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit
Exclusion
- Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
- Prior treatment with PegIntron (combined with ribavirin or not)
- History of alcohol abuse in the past 6 months
- Decompensated liver disease
- Severe heart disease
- Decompensated thyroid disorder
- Neoplasia
- Type 1 diabetes mellitus - uncontrolled or hardly controlled
- Seizures - uncontrolled
- Primary immune deficiency
- Men and women not using appropriate contraceptive methods
- Pregnancy or lactation
- For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm\^3
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1146 Patients enrolled
Trial Details
Trial ID
NCT00724854
Start Date
August 1 2006
End Date
September 1 2009
Last Update
February 25 2015
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