Status:
COMPLETED
Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Lead Sponsor:
Foundation for Liver Research
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/II trial of KRN7000 in patients with chronic hepatitis C. Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer. The primary efficacy paramet...
Detailed Description
Phase I/II trial of KRN7000 in patients with chronic hepatitis C. This study is a multicenter double-blind randomized placebo-controlled phase I/II dose-escalation trial. The protocol is conducted in...
Eligibility Criteria
Inclusion
- Chronic hepatitis C Liver biopsy within 3 years of entry into the study HCV RNA \> 10000 copies/mL Age 18-70 years ALT \> 1.2 times ULN written informed consent Adequate contraception
Exclusion
- Cirrhosis Decompensated liver disease ALT \> 10 times ULN Pregnancy Major other illness
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00352235
Start Date
August 1 2003
End Date
May 1 2005
Last Update
July 14 2006
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands, 3000CA