Unique ID issued by UMIN | UMIN000014891 |
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Receipt number | R000017313 |
Scientific Title | 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 |
Date of disclosure of the study information | 2014/08/20 |
Last modified on | 2022/07/15 14:45:59 |
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
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
Japan |
Hepatitis C virus-induced cirrhosis
Hepato-biliary-pancreatic medicine |
Others
NO
To assess safety and efficacy of patients with HCV-induced cirrhosis who received PRI-724 treatment by 12-months observation.
Safety
Adverse events and adverse drug reactions (including subjective symptoms and abnormal laboratory values)
(1)Incidence rate of liver cancer
(2)Child-Pugh Score
(3)Liver biopsy
(4)Serum albumin level
(5)Serum fibrosis marker level(s)
(6)Ascitic fluid level
(7)Improvement rate of lower leg edema
Observational
20 | years-old | <= |
75 | years-old | > |
Male and Female
(1) Patients who were eligible to 1101-study criteria and received PRI-724 treatment with written informed consent signed and dated.
(2) Having provided voluntary written consent for participation in this study.
(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.
18
1st name | Kiminori |
Middle name | |
Last name | Kimura |
Tokyo metropolitan Komagome Hospital
Division of Hepatology
113-8677
3-18-22,Honkomagome ,Bunkyo-ku,Tokyo
03-3823-2101
kiminori_kimura@tmhp.jp
1st name | Kiminori |
Middle name | |
Last name | Kimura |
Tokyo metropolitan Komagome Hospital
Division of Hepatology
113-8677
3-18-22,Honkomagome ,Bunkyo-ku,Tokyo
03-3823-2101
kiminori_kimura@tmhp.jp
Tokyo metropolitan Komagome Hospital
Japan Agency for Medical Research and Development (AMED)
Japanese Governmental office
PRISM Pharma Co.,Ltd.
Komagome Hospital Institutional Review Board
3-18-22,Honkomagome ,Bunkyo-ku,Tokyo,Japan
03-3823-2101
km_koma_chiken@tmhp.jp
YES
NCT02828254
ClinicalTrials.gov
26-0459
東京都立駒込病院(東京都)
2014 | Year | 08 | Month | 20 | Day |
Unpublished
Main results already published
2014 | Year | 06 | Month | 09 | Day |
2014 | Year | 04 | Month | 16 | Day |
2014 | Year | 09 | Month | 01 | Day |
2017 | Year | 03 | Month | 27 | Day |
2017 | Year | 07 | Month | 20 | Day |
2017 | Year | 08 | Month | 21 | Day |
Adverse events (AEs) and Adverse reactions are to be stratified by AEs, cohorts, or Child-Pugh category.
2014 | Year | 08 | Month | 19 | Day |
2022 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017313
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