Unique ID issued by UMIN | UMIN000039350 |
---|---|
Receipt number | R000044745 |
Scientific Title | Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia |
Date of disclosure of the study information | 2020/03/01 |
Last modified on | 2020/01/25 18:00:58 |
Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Japan |
primary biliary cholangitis
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the clinical benefit and safety of pemafibrate in UDCA(ursodeoxycholic acid)-resistant PBC patients.
Safety,Efficacy
Serum ALP, GGT, AST, ALT, T-Bil, T-chol, HDL-chol, TG levels in 12 months.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
pemafibrate for 12 months
bezafibrate for 12 months
20 | years-old | <= |
95 | years-old | >= |
Male and Female
UDCA-resistant PBC patients with dyslipidemia
Exclude patients who meet the following criteria
1) Patients who have already taken pemafibrate
2) Preexisting disorders of being allergic to pemafibrate
3) Pregnant women or breast-feeding women
4) Patients who have already taken statins.
5) Patients by whom principal investigator has determined to be inappropriate as a subject
60
1st name | Yuki |
Middle name | |
Last name | Yamashita |
Shinshu University Hospital
Department of gastroenterology
390-8621
3-1-1 Asahi, Matsumoto-city, Nagano Prefecture
0263-37-2634
ninai@shinshu-u.ac.jp
1st name | Yuki |
Middle name | |
Last name | Yamashita |
Shinshu University Hospital
Department of gastroenterology
390-8621
3-1-1 Asahi, Matsumoto-city, Nagano Prefecture
0263-37-2634
ninai@shinshu-u.ac.jp
Shinshu University Faculty of Medicine, Department of Gastroenterology
Shinshu University Faculty of Medicine, Department of Gastroenterology
Self funding
Shinshu University Faculty of Medicine
3-1-1 Asahi, Matsumoto-city, Nagano Prefecture
0263-37-2580
mdrinri@shinshu-u.ac.jp
NO
2020 | Year | 03 | Month | 01 | Day |
Unpublished
Preinitiation
2020 | Year | 01 | Month | 17 | Day |
2020 | Year | 01 | Month | 21 | Day |
2020 | Year | 03 | Month | 01 | Day |
2025 | Year | 03 | Month | 01 | Day |
2020 | Year | 01 | Month | 31 | Day |
2020 | Year | 01 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044745
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |