UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022568 |
|---|---|
| Receipt number | R000026010 |
| Scientific Title | Special Drug Use Results Survey of Targretin capsules 75-mg in patients with Cutaneous T-cell Lymphomas |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2021/12/09 10:00:38 |
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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
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
gvp@minophagen.co.jp
Sponsor or person
Institute
Minophagen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026010
