A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
NCT ID: NCT02015312
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2013-04-30
2017-10-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Epigallocatechin-3-gallate (EGCG)
EGCG 400 mg/d p.o. for 3 months; 800 mg/d p.o. for 3 months, 1200 mg/d p.o. for 6 months
Epigallocatechin-3-gallate (EGCG)
Pharmaceutical formulation: capsules
Dose:
400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Placebo
capsules
Dose:
400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Placebo
Pharmaceutical formulation: capsules
Dose:
400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Interventions
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Epigallocatechin-3-gallate (EGCG)
Pharmaceutical formulation: capsules
Dose:
400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Placebo
Pharmaceutical formulation: capsules
Dose:
400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cardiac involvement with septum thickness more than 12 mm (without other causes as published by Gertz et al., hypertension or other potential causes of left ventricular hypertrophy)
* Previously treated with chemotherapy, induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder.
* GPT and GOT less than 3-times ULN.
* Life expectancy more than 12 month.
* Ability of subject to understand character and individual consequences of the clinical trail.
* Written informed consent.
* For women with childbearing potential and men, adequate contraception.
Exclusion Criteria
* Concomitant multiple myeloma stage 2 and 3 (Salmon and Durie)
* Concurrent chemotherapy necessary
* Time to last chemotherapy more than 6 months.
* Chronic liver disease, Bilirubin over 1,5 mg/dl
* Not able to visit Amyloidosis Clinic in Heidelberg every 3 months.
* History of hypersensitivity to the investigational product or to any substance with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials or observation period of competing trials, respectively.
* Pregnant or nursing women.
18 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Florian Michel
OTHER
Responsible Party
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Florian Michel
Study Coordinator
Principal Investigators
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Stefan Schönland, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Heidelberg
Locations
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University Hospital of Heidelberg; Medical Department V
Heidelberg, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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2012-004520-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TAME-AL
Identifier Type: -
Identifier Source: org_study_id