臨床研究等提出・公開システム

Japanese

Date of registration	May. 25, 2022
Last modified on	July. 09, 2024
Trial ID	jRCT2051220026

Scientific Title	Clinical Study of OP-07 for Delayed Methotrexate Elimination with Methotrexate-Leucovorin Rescue Therapy (OP-07-002 study)
Public Title	Clinical Study of OP-07 for Delayed Methotrexate Elimination with Methotrexate-Leucovorin Rescue Therapy (OP-07-002 study)

Completion date	Jan. 31, 2024
Result actual enrolment	8
Baseline Characteristics	5 subjects (62.5%) were male, the median (minimum and maximum) age was 7.5 years (6, 14), and the target diseases were acute lymphoblastic leukemia in 5 subjects (62.5%) and osteosarcoma in 3 subjects (37.5%). A total of 4 (50.0%) each had signs of acute kidney injury.
Participant flow	A total of 8 subjects consented, 8 subjects were assessed for eligibility, 8 subjects were eligible, 8 subjects were enrolled and treated, 8 subjects completed follow-up, and 8 subjects were included in the analysis.
Adverse events	Adverse Events occurred in all 8 subjects (100.0%). Adverse events that occurred in >=30% of subjects were vomiting, neutrophil count decreased, platelet count decreased, and white blood cell count decreased in 3 subjects (37.5%) each.Adverse reactions were not observed.Among the 2 subjects (25.0%) with Grade>= 3 adverse events, 1 subject had Grade 4 hypokalaemia (not related to study drug).A serious adverse event of Grade 4 hypokalemia was reported in 1 subject (not related to study drug).Although an abnormally high serum creatinine level was observed in laboratory tests, the grade changed before treatment in only 2 patients.As for vital signs, etc., there were no special items.
Outcome measures	All 8 subjects had lower blood MTX concentrations at 48 hours post-dose than before the first dose of OP-07.the mean (SD) change in blood MTX concentration the mean (SD) change in blood MTX concentration, was-5.873 (5.734) , and the mean (SD) reduction was 93.96% (1.97).Also, 7 of the 8 subjects (87.5%) had blood MTX concentrations<1umol/L 48 hours after the first dose of OP-07.
Brief summary	Efficacy results of this study were generally similar to the results of the main Phase II study in Japan that reported the effect of OP-07 in blood MTX levels.Adverse events observed in this study were known.Based on the results of this study, the efficacy of OP-07 in patients with delayed MTX excretion during MTX-LV rescue therapy was confirmed, and no new safety concerns were raised.
Date of posting of results summaries	June. 30, 2024
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCT2051220026

Contact for Scientific Queries	Name	Watanabe Tatsuo
	Affiliation	Ohara Pharmaceutical Co., Ltd.
	Address	8-1 Akashi-cho, Chuo-ku, Tokyo
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp
Contact for Public Queries	Name	Customer Consulation Room
	Affiliation	Ohara Pharmaceutical Co., Ltd.
	Address	8-1 Akashi-cho, Chuo-ku, Tokyo
	Telephone	+81-120-419-363
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 25, 2022
Actual date of first enrollment		July. 27, 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	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients whose written informed consent to participate in this study has been obtained from the patient or his/her legally authorized representative 2. Patients with delayed MTX elimination during MTX-LV rescue therapy. Delayed MTX elimination should be referred to the following blood MTX concentrations as a guide. -Time elapsed after administration of MTX (24 hours), with or without any signs of acute kidney injury; 50 micro mol/L -Time elapsed after administration of MTX (42 hours), without any signs of acute kidney injury; >= 5 micro mol/L -Time elapsed after administration of MTX (42 hours), with any sign of acute kidney injury; >= 1 micro mol/L -Time elapsed after administration of MTX (48 hours), without any signs of acute kidney injury; >= 2 micro mol/L -Time elapsed after administration of MTX (48 hours), with any sign of acute kidney injury; >= 0.4 micro mol/L
	Exclusion Criteria	1.Patients with a history of serious hypersensitivity to any of the ingredients of OP-07 2.Any patients for whom the investigator or subinvestigator considered the risks outweighing the benefits of dosing OP-07
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Subjects with delayed MTX elimination after MTX/LV rescue therapy
Intervention(s)		Administered intravenously as 50 U/kg of OP-07 for 5 minutes. When the blood MTX concentration at 48 hours after the initial dose is >= 1 micro mol/L, an additional dose of OP-07 can be administered at the same dosage and administration as the first time.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety endpoints:Adverse events Efficacy endpoints:Blood MTX concentration 48 hours after the initial dose of OP-07
Secondary Outcome(s)

Primary Sponsor	Ohara Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Osaka City General Hospital Funded Research Review Committee
Address	2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka-shi, Osaka, Osaka
Telephone	+81-6-6929-1221
E-Mail
Approval Status	Approval
Date of approval	April. 22, 2022

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 09, 2024	(this page)	Changes
3	Feb. 12, 2023	Detail	Changes
2	Sept. 03, 2022	Detail	Changes
1	May. 25, 2022	Detail

List of change history