Status:
COMPLETED
The Effect of Diflunisal on Familial Transthyretin Amyloidosis
Lead Sponsor:
Umeå University
Conditions:
Amyloidosis
Eligibility:
All Genders
18+ years
Brief Summary
An ongoing trial of diflunisal has been closed for enrollment, thus, patients suitable for the study can no longer participate or receive treatment by diflunisal; and patients, who have participated i...
Detailed Description
Duration of treatment in this study is dependent of the results from the ongoing IND 68092-study, which are planned to be presented 2013.
Eligibility Criteria
Inclusion
- Biopsy and genetically proven systemic transthyretin amyloidosis caused by a TTR gene mutation. The amyloid shall be proven to be of transthyretin type, and the fibril composition settled.
- Age ≥ 18 years.
- Negative pregnancy test and contraception for sexually active women of child bearing potential.
Exclusion
- Concomitant use of non-study non-steroidal anti-inflammatory drugs (NSAIDs)
- Heart failure with symptoms at daily activities (NYHA class ≥III)
- Renal insufficiency (creatinine clearance \< 30 ml calculated from the Cockcroft-Gault formula)
- Active non-haemorrhoidal bleeding within the last 18 month.
- Non-treated peptic ulcer disease.
- Anticoagulation therapy, low dose ASA permitted.
- Non-steroidal or aspirin allergy/hypersensitivity
- Thrombocytopenia (\< 100,000 platelets/mm3)
- Inability or unwillingness of subject to give written informed consent
- By the investigator regarded as unable to follow the study guidelines and scheduled controls.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01432587
Start Date
August 1 2011
End Date
December 1 2014
Last Update
August 24 2015
Active Locations (3)
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1
Dept of Clinical Medicin, Ptieå Hospital
Piteå, Sweden, SE-941 28
2
Dept of clinical medicin, Skellefteå Hospital
Skellefteå, Sweden, SE-931 86
3
Dept of Clinical Medicine, Umeå University Hospital
Umeå, Sweden, SE-90185