臨床研究等提出・公開システム

Date of registration	Feb. 01, 2023
Last modified on	July. 24, 2025
Trial ID	jRCT2033220602

Scientific Title	Continuous observation study after administration of ADR-001 in patients with Compensated Liver Cirrhosis
Public Title	ADR-001-N2

Contact for Scientific Queries	Name	Terai Shuji
	Affiliation	Niigata University Medical and Dental Hospital
	Address	754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata
	Telephone	+81-25-227-2207
	E-mail	terais@med.niigata-u.ac.jp
Contact for Public Queries	Name	Watanabe Yusuke
	Affiliation	Niigata University Medical and Dental Hospital
	Address	754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata
	Telephone	+81-25-227-2207
	E-mail	ywatanabe19840421@med.niigata-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 30, 2023
Actual date of first enrollment		Feb. 14, 2023
Target sample size		9
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patients who received at least one dose of ADR-001 in the ADR-001-N1 Study. 2)Patients capable of giving written informed consent.
	Exclusion Criteria	1)Patients decided to be ineligible for this study by the investigator.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Compensated liver cirrhosis (Child-Pugh A)
Primary Outcome(s)		The amount of change in Albumin-bilirubin (ALBI) score

Source of Monetary Support	ROHTO Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Niigata University Medical and Dental Hospital IRB
Address	754,Ichibancho,Asahimachidori,Chuo-ku,Niigata-shi., Niigata
Telephone	+81-25-227-0901
E-Mail	jimukyoku_ctrc@nuh.niigata-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 27, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 24, 2025	(this page)	Changes
3	July. 01, 2023	Detail	Changes
2	Feb. 23, 2023	Detail	Changes
1	Feb. 01, 2023	Detail

List of change history