Study to assess the efficacy clinical trial and safety of intranasal administration of ethamsylate in the treatment of hereditary hemorrhagic telangiectasia, during 4 weeks
- Conditions
- Hereditary hemorrhagic telangiectasiaMedDRA version: 19.0 Level: LLT Classification code 10020023 Term: HHT System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2016-003982-24-ES
- Lead Sponsor
- Asociación HHT España
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
• Adult patients (18 years or more) of both sexes.
• Diagnosis of HHT.
• High propensity for nosebleeds
• Patients with ability and willingness to follow the study protocol and give their informed consent (signed and dated), agreeing to participate voluntarily in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Do not sign the informed to participate in the study after being informed by the investigator on the target, the course and potential risks of the study consent.
• Patients who can not meet the requirements of the study or in the investigator's opinion should not participate in the study.
• Patients with concomitant diseases, according to the researcher may influence (by the disease itself and / or its treatment) in the development, evolution or valuation of HHT.
• Patients who have received anti-inflammatory treatment in the last month.
• Patients in whom the use of Ethamsylate is contraindicated.
• Pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method