UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019732
Receipt No. R000022783
Scientific Title A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
Date of disclosure of the study information 2015/11/11
Last modified on 2016/08/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
Acronym The high-dose EGCG therapy for AL-Amyloidosis.
Scientific Title A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
Scientific Title:Acronym The high-dose EGCG therapy for AL-Amyloidosis.
Region
Japan

Condition
Condition ligh chain amyloidosis
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with light-chain amyloidosis. Evaluation of clinical efficacy of EGCG intake.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes compare the 3 and 6 month change in each organ involvement such as cardiac troponin T, NT-proBNP, interventricular septum thickness, ejection fraction, quantitative immunoglobulins, serum beta2 microglobulin, serum-free light chains, urinary albumin, derivatives of reactive oxygen metabolites, and biochemical antioxidant potential.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 standerd therapy plus the high dose green tea therapy.
Drug: green tea extract powder
Pharmaceutical formulation: capsules
dose 2400 mg/d p.o. for 6 months every day
Interventions/Control_2 standerd therapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Biopsy proven systemic AL amyloidosis.
2. At least one evaluable organ involvement.
3. Ability of subject to understand character and individual consequences of the clinical trail.
4. Written informed consent.
5. Ability of subject to intake capsules.
Key exclusion criteria 1.Age less than 20 years.
2.Not able to visit Japanese Red Cross Medical Center every 3 months.
3.History of any hypersensitivity or allergic reactions to the green tea ingredients.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sohsuke Meshitsuka
Organization Japanese Red Cross Medical Center
Division name Division of Hematology
Zip code
Address 4-1-22 hiroo sibuya tokyo
TEL 03-3400-1311
Email meshitsuka_sosuke@med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sohsuke Meshitsuka
Organization Japanese Red Cross Medical Center
Division name Division of Hematology
Zip code
Address 4-1-22 hiroo sibuya tokyo
TEL 03-3400-1311
Homepage URL
Email meshitsuka_sosuke@med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Medical Center, Division of Hematology
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
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
2015 Year 11 Month 11 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
2015 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 10 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.