Status:
COMPLETED
Doxycycline for Hereditary Hemorrhagic Telangiectasia
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Barrow Neurological Institute
Duke University
Conditions:
Hereditary Hemorrhagic Telangiectasia (HHT)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will investigate the effectiveness of oral doxycycline for the treatment of recurrent nasal hemorrhage in Hereditary Hemorrhagic Telangiectasia (HHT) subjects. The primary outcome for the t...
Detailed Description
The aim is to study is to evaluate doxycycline as a treatment for HHT with the proposed "HHT Clinical Trial Protocol". Rare disease presents a number of challenges in clinical trial design, including ...
Eligibility Criteria
Inclusion
- Age \>+ 18 years
- Clinical HHT diagnosis or genetic diagnosis of HHT
- Known personal or familial endoglin (ENG), ALK1 or SMAD4 mutation
- Epistaxis at least 15 min per week (mean for past month)
- At least two skin telangiectases
- \>2mm diameter available for excisional biopsy,
- at least two other telangiectases (skin or mucosal) available for micro-imaging
- Ability to give written informed consent
- including compliance with the requirements of the study
Exclusion
- Allergy/intolerance to the study drug or related agents
- Unstable medical illness
- Acute infection
- Creatinine \> upper limit of normal (ULN)
- Liver transaminases (AST or ALT) \>= 2x ULN
- Recent (within 2 month) use of study drug or other tetracycline agents
- Women who are pregnant
- Breastfeeding
- Plan to become pregnant during of the study
- Beta human chorionic gonadotropin (BHCG) level \<6 IUL (re-test if 6-24 IU/L)
- Specific contra-indications for study drug
Key Trial Info
Start Date :
September 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03397004
Start Date
September 12 2018
End Date
March 1 2021
Last Update
April 1 2025
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8