臨床研究等提出・公開システム

Japanese

Date of registration	July. 01, 2023
Last modified on	Oct. 09, 2025
Trial ID	jRCT2031230195

Scientific Title	A multi-center, placebo-controlled, randomized, double-blind phase 2 trial of foscenvivint in patients with decompensated cirrhosis related with HCV, HBV, or NASH
Public Title	OP-724-002 study

Contact for Scientific Queries	Name	Sasaki Noriyuki
	Affiliation	Ohara pharmaceutical Co., Ltd.
	Address	8-1 Akashi-tyo, Chuo-ku, Tokyo
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp
Contact for Public Queries	Name	Department of Clinical Development
	Affiliation	Ohara pharmaceutical Co., Ltd.
	Address	8-1 Akashi-tyo, Chuo-ku, Tokyo
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 01, 2023
Actual date of first enrollment		Oct. 16, 2023
Target sample size		93
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with decompansated cirrhosis (Child-Pugh class B: Score 7-9) 2. Patients with liver cirrhosis related with HCV, HBV, or NASH 3. Patients with performance Status: 0-2 4. Patients with serum albumin levels =<3.5 g/dL
	Exclusion Criteria	1. Patients with decompansated cirrhosis of which cause is unknown 2. Patients with refractory ascites 3. Patients with complication or history of malignant tumor (within 3 years before screening, excepting the patients with no relapse of hepatocellular carcinoma during more than 1 year from surgical treatment etc.)
	Age Minimum	18age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Decompensated cirrhosis related with HCV, HBV or NASH
Intervention(s)		Cohort A (HCV, HBV) : - foscenvivint iv. twice a week - foscenvivint iv. once a week and placebo iv. once a week - Placebo iv. twice a week Cohort B (NASH) : - foscenvivint iv. twice a week - Placebo iv. twice a week Administration period: 24weeks, Observation period: 52weeks
Health Condition(s) Keyword		Decompensated cirrhosis, HCV, HBV, NASH
Intervention(s) Keyword		CBP/beta-catenin inhibitor
Health Condition(s) Code		D008103
Intervention(s) Code		D060449
Primary Outcome(s)		Child-Pugh score
Secondary Outcome(s)		Child-Pugh score, ALBI score, Liver stiffness, Serum fibrosis markers, etc.

Primary Sponsor	Ohara pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor	AMED (Japan Agency for Medical Research and Development)

Name of Certified Review Board	IRB of Nihon University Hospital
Address	30-1, Oyaguchikamicho, Itabasi-ku, Tokyo
Approval Status	Approval
Date of approval	June. 30, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
9	Oct. 09, 2025	(this page)	Changes
8	Sept. 18, 2024	Detail	Changes
7	July. 12, 2024	Detail	Changes
6	Mar. 15, 2024	Detail	Changes
5	Jan. 30, 2024	Detail	Changes
4	Dec. 18, 2023	Detail	Changes
3	Oct. 31, 2023	Detail	Changes
2	Aug. 30, 2023	Detail	Changes
1	July. 01, 2023	Detail

List of change history