Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy

Completed · Phase 1/Phase 2

Conditions studied: Amyloidosis; Heart (Manifestation), Senile Cardiac Amyloidosis

In brief

The objective of the study is to determine whether the combination of the bile acid TUDCA, and doxycycline will slow the progression of familial and senile amyloidosis.

Key facts

Study ID

NCT01855360

Run by

Brigham and Women's Hospital

People needed

40

Starts

2013-06-01

Expected to finish

2015-05-31

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented transthyretin cardiac amyloidosis by biopsy and staining using immunohistochemistry or mass spectrometry
• Echocardiographic appearance of left ventricular wall thickness of 13mm or more in the absence of hypertensive heart disease
• Confirmed ATTR or SSA by genetic testing
• Age 18-90
• Male or non-pregnant, non-lactating females
• Willingness to return to the treatment center for follow-up

You may not qualify if…

• Prior liver transplantation or liver transplantation anticipated in less than 6 months
• Alanine Transaminase and/or Aspartate Transaminase ≥2 x upper normal limit (UNL)
• Alkaline Phosphatase ≥2 x UNL
• Creatinine clearance <20 mL/min
• Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study
• History of poor compliance
• History of hypersensitivity to any of the ingredients of the study therapies
• Any investigational drug within 4 weeks prior to study entry or during the study
• Current use of diflunisal for therapy of amyloidosis

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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