UMIN-CTR Clinical Trial

Basic information
Public title	Special Drug Use Results Survey of Targretin capsules 75-mg in patients with Cutaneous T-cell Lymphomas
Acronym	Targretin Special Drug Use Surveillance (CTCL)
Scientific Title	Special Drug Use Results Survey of Targretin capsules 75-mg in patients with Cutaneous T-cell Lymphomas
Scientific Title:Acronym	Targretin Special Drug Use Surveillance (CTCL)
Region	Japan

Condition
Condition	Cutaneous T-Cell Lymphomas
Classification by specialty	Hematology and clinical oncology Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary objective is to determine the following items under the conditions of actual clinical use of Targretin according to the post-approval commitments: 1. Unlabeled adverse drug reactions (ADR) 2. Incidence of ADRs 3. Factors thought to affect safety and efficacy 4. Safety and efficacy of CTCL variant 5. Clinical information before the therapy 6. Incidence of selected ADRs 7. Safety and overall Survival following the B-1201 clinical study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety, Efficacy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients planning to use Targretin during the enrollment period
Key exclusion criteria	No criteria
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kosuke Middle name Last name Shii
Organization	Minophagen Pharmaceutical Co., Ltd.
Division name	Pharmacovigilance Department
Zip code	1600023
Address	3-2-11, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-5909-2131
Email	gvp@minophagen.co.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Shii
Organization	Minophagen Pharmaceutical Co., Ltd.
Division name	Pharmacovigilance Department
Zip code	1600023
Address	3-2-11, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-5909-2131
Homepage URL
Email	gvp@minophagen.co.jp

Sponsor
Institute	Minophagen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Minophagen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NA
Address	NA
Tel	NA
Email	NA

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 25 Day
Date of IRB	2016 Year 05 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 23 Day
Last follow-up date	2020 Year 02 Month 05 Day
Date of closure to data entry	2020 Year 02 Month 14 Day
Date trial data considered complete	2020 Year 02 Month 14 Day
Date analysis concluded	2020 Year 09 Month 17 Day

Other
Other related information	Research ethics review is not necessary

Management information
Registered date	2016 Year 06 Month 01 Day
Last modified on	2021 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026010