Status:
COMPLETED
Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antivira...
Eligibility Criteria
Inclusion
- Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
- Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
- Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \[ALT\]) levels above the upper normal limit for gender
- Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
- A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4
Exclusion
- Known hypersensitivity for any active ingredient or constituent
- Pregnancy or lactation
- Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
- Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
- Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \<50 mL/minute
- Hepatitis of immunologic origin or medically documented history of auto-immune disease
- Severe hepatic disorder or decompensated cirrhosis
- Pre-existing thyroid disorder, except if under control with classical treatment
- Epilepsy or central nervous system disorder
- Hemoglobin pathology, eg, thalassaemia, sickle cell anemia
Key Trial Info
Start Date :
December 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT00709059
Start Date
December 1 2004
End Date
December 1 2009
Last Update
November 4 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.