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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021963
Receipt No. 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 2019/11/26

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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
Email 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
Email fnomura@ITS.JNJ.com

Sponsor
Institute Janssen Pharmaceutical K.K.
Institute
Department

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
Email

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 Enrolling by invitation
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
2019 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.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


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