JPRN-UMIN000014891Completed未知
An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy - An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy
Tokyo metropolitan Komagome Hospital0 sites18 target enrollmentStarted: August 20, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20years-old to 75years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1)Female patients who are pregnant or suspected to be pregnant. (2) Male patients who do not consent to using reliable contraception methods for 12 weeks after the end of infusion of PRI-724 in 1101 study. (3)Patients contraindicated for liver biopsy. Unless the patients were found to be contraindicated for liver biopsy after receiving PRI-724 in 1101 study. (4) Patients who were enrolled in other clinical study other than 1101-study within 30 days prior the consent. (5) 1101-study termination with follow-up failure due to pass-away or other reasons. (6) Patients judged by investigators ineligible due to seriousness of patients condition.
Investigators
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