Status:
COMPLETED
Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effec...
Eligibility Criteria
Inclusion
- Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:
- At least 20 years of age and willing to sign an informed consent
- Patients who can practice contraception
- Patients who are classified either as relapsers or non-responders.
- Weight between 45 and 100 kg
- Patients willing to be hospitalized for 3 days after the start of treatment
- Patients with positive HCV-RNA
- Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
- Neutrophil count: equal to or more than 1,200 /mm\^3
- Platelet count：equal to or more than 100,000/mm\^3
Exclusion
- Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00787371
Start Date
June 1 2005
End Date
July 1 2006
Last Update
March 13 2017
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.