NCT02015312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2017

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

4.5 years

First QC Date

November 18, 2013

Last Update Submit

October 16, 2017

Conditions

Light Chain (AL) AmyloidosisCardiac Involvement

Keywords

Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • compare the 12 month change in left ventricular mass

    The primary analysis to compare the 12 month change in left ventricular mass between the two treatment arms will be performed by a one-sided two-sample t test at a significance level of 0.025.

    12 month

Secondary Outcomes (6)

  • Change in Quality of Life

    baseline, 12 month

  • safety of EGCG

    12 month

  • change in cardiac biomarkers

    Baseline, 12 Month

  • improvement of hematological remission

    Baseline, 12 Month

  • Organ response in affected organs other than heart

    Baseline, 12 Month

  • +1 more secondary outcomes

Study Arms (2)

Epigallocatechin-3-gallate (EGCG)

EXPERIMENTAL

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

Drug: Epigallocatechin-3-gallate (EGCG)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Epigallocatechin-3-gallate (EGCG)DRUG

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

Also known as: Epigallocatechin gallate, EGCG, Epigallocatechin 3-gallate, Tea catechin, Epigallocatechin-3-gallate
Epigallocatechin-3-gallate (EGCG)
PlaceboDRUG

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

Also known as: Mannitol 99.5% + highly dispersed silicon dioxide 0.5%
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Heidelberg; Medical Department V

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

epigallocatechin gallateepigallocatechin-3-(3''-O-methyl)gallateMannitol

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Stefan Schönland, MD

    University Hospital of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

November 18, 2013

First Posted

December 19, 2013

Study Start

April 1, 2013

Primary Completion

October 11, 2017

Study Completion

October 11, 2017

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

DE(1)