A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-… (NCT02015312) | Clinical Trial Compass
CompletedPhase 2
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Germany38 participantsStarted 2013-04
Plain-language summary
Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy proven systemic AL amyloidosis.
* 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:
* Age less than 18 years.
* 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.
What they're measuring
1
compare the 12 month change in left ventricular mass