Study to assess the efficacy clinical trial and safety of intranasal administration of ethamsylate in the treatment of hereditary hemorrhagic telangiectasia, during 4 weeks

A phase IV-II, single-center, open, single arm treatment, low level of intervention, to assess the efficacy clinical trial and safety of intranasal administration of ethamsylate in the treatment of hereditary hemorrhagic telangiectasia, during 4 weeks

Status

Active, not recruiting

Phases

Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003982-24-ES

Enrollment

Registered

2016-12-09

Start date

2017-03-16

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary hemorrhagic telangiectasia MedDRA version: 19.0 Level: LLT Classification code 10020023 Term: HHT System Organ Class: 100000004850

Interventions

Trade Name: Dicynone Pharmaceutical Form: INN or Proposed INN: Etamsylate CAS Number: 2624444 Current Sponsor code: Etamsylate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of daily administration of intranasal Ethamsylate in improving the HHT at 4 weeks of starting treatment, by measuring the number of epistaxis per week and features.; Primary end point(s): •number of epistaxis per week •bleeding time •amount of bleeding •evolution of anemia ; Timepoint(s) of evaluation of this end point: •endoscopic image of the nasal mucosa telangiectasia •overall evaluation of study treatment •assessment of quality of life ; Secondary Objective: • Evaluate the effect of daily intranasal administration of Ethamsylate to reverse anemia (Hb, hematocrit, reticulocytes, erythropoietin, etc.) associated with HHT, at 4 weeks of starting treatment. • To evaluate the incidence of adverse events according to their severity, severity, relationship to treatment with intranasal Ethamsylate during 4 weeks of treatment, and the effect on the quality of life of patients.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of daily administration of intranasal Ethamsylate in improving the HHT at 4 weeks of starting treatment, by measuring the number of epistaxis per week and features.; Primary end point(s): •number of epistaxis per week •bleeding time •amount of bleeding •evolution of anemia ; Timepoint(s) of evaluation of this end point: •endoscopic image of the nasal mucosa telangiectasia •overall evaluation of study treatment •assessment of quality of life ; Secondary Objective: • Evaluate the effect of daily intranasal administration of Ethamsylate to reverse anemia (Hb, hematocrit, reticulocytes, erythropoietin, etc.) associated with HHT, at 4 weeks of starting treatment. • To evaluate the incidence of adverse events according to their severity, severity, relationship to treatment with intranasal Ethamsylate during 4 weeks of treatment, and the effect on the quality of life of patients.

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Secondary

Measure	Time frame
Secondary end point(s): 4 semanas;Timepoint(s) of evaluation of this end point: 4 weeks	—

Countries

Spain

Contacts

Public ContactBienvenido Muñoz

Asociación HHT España

0034630904306

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026