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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name