Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis
NCT02016365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2016-05-12
Summary
The primary objective for this study is to evaluate the efficacy of doxycycline + ursodeoxycholic acid (UDCA) on disease progression in Transthyretin Amyloidosis (ATTR) subjects with cardiomyopathy with or without neuropathy.
Conditions
- Transthyretin Amyloidosis
- Cardiomyopathy
Interventions
- DRUG
-
Doxycycline
200 mg/day (100 mg twice daily, orally) for 4 weeks with a pause of 2 weeks in combination with UDCA
- DRUG
-
Ursodeoxycholic acid
750 mg/day (500 mg +250mg orally) continuously
Sponsors & Collaborators
-
Umeå University
lead OTHER
Principal Investigators
-
Ole B Suhr, MD PhD Prof · Dept of Clinical Medicine and public Health, Umeå University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- Sweden
Study Locations
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