JRCT ID: jRCT2031210625
Registered date:23/02/2022
Special Drug Use-results Survey of Targretin Capsules combined with photo(chemo)therapy
Basic Information
Recruitment status | Suspended |
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Health condition(s) or Problem(s) studied | Cutaneous T-cell lymphoma |
Date of first enrollment | 01/02/2022 |
Target sample size | 70 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Incidence of photosensitivity and similar skin adverse events and their 95% confidence intervals |
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Secondary Outcome | The incidence of adverse events by System Organ Class(SOC) and Preferred Term(PT) using MedDRA / J and its 95% confidence interval Response rate (CR + PR) and its confidence interval based on the best overall effect of mSWAT. |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | (1) Cases in which UV therapy is being performed and the combined use of bexarotene and UV therapy is started during the registration period. However, if bexarotene has been used, cases that have not been administered for more than 4 weeks since the last administration (2) Cases registered for the first time in this survey (3) Patients who have been treated with UV therapy at a standard frequency (at least once a week) for about one month before the start of concomitant use with bexarotene, and the status of the treatment can be confirmed. (4) Cases in which the consent of the patient was obtained |
Exclude criteria | adult T-cell leukemia/lymphoma |
Related Information
Primary Sponsor | pharmacovigilance departmant |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | department pharmacovigilance |
Address | Shinjuku Mitsui Bldg #2, 3-2-11, Nishi-Shinjuku Shinjuku-ku, Tokyo Tokyo Japan 160-002 |
Telephone | +81-3-5909-2323 |
gvp@minophagen.co.jp | |
Affiliation | Minophagen Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | departmant pharmacovigilance |
Address | Shinjuku Mitsui Bldg #2, 3-2-11, Nishi-Shinjuku Shinjuku-ku, Tokyo Tokyo Japan 160-002 |
Telephone | +81-3-5909-2323 |
gvp@minophagen.co.jp | |
Affiliation | Minophagen Pharmaceutical Co., LTD. |