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Tacrolimus Trial for Hereditary Hemorrhagic Telangiectasia (HHT)

NCT04646356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-01

No results posted yet for this study

Summary

This study will investigate the effectiveness of oral low-dose tacrolimus for the treatment of recurrent nasal hemorrhage in 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. In this Phase II open label trial, we estimate a sample size of 30 subjects with HHT, with moderate-severe recurrent epistaxis will be required. Subject will be treated with a 6-month course of tacrolimus twice daily.

Conditions

  • Hereditary Hemorrhagic Telangiectasia
  • Epistaxis Nosebleed

Interventions

DRUG

Tacrolimus capsule (low-dose)

low-dose Tacrolimus will be given for 6 months followed by a washout period for 6 months

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Marie E Faughnan, MD,MSc,FRCPC · Unity Health Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2024-01-15
Completion
2024-10-21

Countries

  • Canada

Study Locations

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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 NCT04646356 on ClinicalTrials.gov