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Doxycycline for Hereditary Hemorrhagic Telangiectasia

NCT03397004 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-04-01

No results posted yet for this study

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 trials will be the reduction of epistaxis severity (minutes of bleeding per week). The biological outcomes of interest are the regression of vascular malformations as well as tissue and circulation biomarkers of the relevant mechanistic pathways. A Phase II, randomized double-blind placebo-controlled crossover trial. Approximately 30 subjects with HHT, with moderate-severe recurrent epistaxis will participate in the randomized double-blind placebo-controlled cross over trial. Subject will be treated with a 6-month course of doxycycline 100mg twice daily or placebo twice daily.

Conditions

  • Hereditary Hemorrhagic Telangiectasia (HHT)

Interventions

DRUG

Doxycycline Hyclate

Doxycycline will be given for 6 months, followed by a washout period for 6 months (pre or post a crossover intervention)

DRUG

Placebo

Placebo will be given for 6 months, followed by a washout period for 6 months (pre or post a crossover intervention)

Sponsors & Collaborators

  • Barrow Neurological Institute

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Feinstein Institute for Medical Research

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Marie E Faughnan, MD MSc FRCPC · St. Michael's Hospital / The University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2021-02-18
Completion
2021-03-01

Countries

  • Canada

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397004 on ClinicalTrials.gov