UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract.
Title of the study (Brief title)	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	Sohsuke Meshitsuka
Organization	Japanese Red Cross Medical Center
Division name	Division of Hematology
Address	4-1-22 hiroo sibuya tokyo
TEL	03-3400-1311
Email	meshitsuka_sosuke@med.jrc.or.jp

Public contact
Name of contact person	Sohsuke Meshitsuka
Organization	Japanese Red Cross Medical Center
Division name	Division of Hematology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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