臨床研究等提出・公開システム

Date of registration	Jan. 21, 2022
Last modified on	April. 01, 2026
Trial ID	jRCT2031210566

Scientific Title	Follow ups of patients in AK1830 Phase II Studies
Public Title	Follow ups of patients in AK1830 Phase II Studies

Contact for Scientific Queries	Name	Kudo Katsuyasu
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Clinical Trial Information Contact for
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 01, 2022
Actual date of first enrollment		Feb. 28, 2022
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who provided written informed consent to participate in the clinical study and who met all of the following criteria [1] Patients who participated in the AK1830 Phase II Study and were deemed to require follow up. [2] Patients who fully understand the contents of the study and are capable of providing informed consent
	Exclusion Criteria	Patients who met any of the following criteria are to be excluded. [1] Patients who have received their long-term safety outcomes in the AK1830 Phase II Study [2] Patients deemed by the investigator or sub-investigator to be unsuitable for study participation
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		osteoarthritis, chronic lumbar pain
Intervention(s)		diagnostic imaging (No study drug administration during the follow up)
Primary Outcome(s)		image evaluations

Primary Sponsor	ASAHI KASEI THERAPEUTICS CORPORATION

Name of Certified Review Board	Jimbo Orthopedics Institutional Review Board
Address	5-38-41, Honcho, Koganei-shi, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-cirb-jinbo@cmicgroup.com
Approval Status	Approval
Date of approval	Dec. 14, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	April. 01, 2026	(this page)	Changes
4	Sept. 15, 2022	Detail	Changes
3	May. 25, 2022	Detail	Changes
2	Mar. 09, 2022	Detail	Changes
1	Jan. 21, 2022	Detail

List of change history