Overview
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Status:
Completed
Completed
Trial end date:
2017-10-11
2017-10-11
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Florian MichelCollaborator:
German Federal Ministry of Education and ResearchTreatments:
Epigallocatechin gallate
Mannitol
Silicon
Criteria
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.