UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021963 |
|---|---|
| Receipt number | R000025320 |
| Scientific Title | Special Drug Use-Results Survey for IMBRUVICA Capsules 140 mg |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2023/11/01 20:46:59 |
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Basic information
Public title
Special Drug Use-Results Survey for IMBRUVICA Capsules 140 mg
Acronym
Special Drug Use-Results Survey for IMBRUVICA Capsules 140 mg
Scientific Title
Special Drug Use-Results Survey for IMBRUVICA Capsules 140 mg
Scientific Title:Acronym
Special Drug Use-Results Survey for IMBRUVICA Capsules 140 mg
Region
| Japan |
Condition
Condition
Relapsed or refractory chronic lymphocytic leukemia, including patients with small lymphocytic lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of IMBRUVICA Capsules 140 mg under actual conditions of long-term use in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) (including patients with small lymphocytic lymphoma (SLL)).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety(Adverse Drug Reaction)
Effectiveness
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 who administered IMBRUVICA
Key exclusion criteria
NA
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Kato |
Organization
Janssen Pharmaceutical K.K.
Division name
Safety Risk Management Dept.
Zip code
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL
03-4411-5478
tkato1@its.jnj.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumi Nomura |
Organization
Janssen Pharmaceutical K.K.
Division name
Safety Risk Management Dept.
Zip code
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL
03-4411-8110
Homepage URL
fnomura@ITS.JNJ.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
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
Address
Tel
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 | 05 | Month | 09 | 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 | 04 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective study. All case survey conducted under approval condition and GPSP.
Objectives: To evaluate the safety and efficacy under actual conditions of long-term use in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) (including patients with small lymphocytic lymphoma (SLL)).
Survey patients: All patients who received IMBRUVICA.
Registration period: May 2016 - Oct 2019(3 year and 6 months from the starting day of the distribution of IMBRUVICA).
Observation items: Patient background, History of prior treatment, Record of IMBRUVICA treatment, Concomitant therapies, Safety evaluation, Efficacy evaluation etc.
Management information
Registered date
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025320
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
