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COMPLETED
NCT05269849
PHASE2

Sirolimus for Nosebleeds in HHT

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

Summary

This pilot study is to determine the safety and efficacy of oral sirolimus (blood trough level 6-10ng/ml) in patients with HHT that are experiencing moderate or severe epistaxis. The effect of oral sirolimus on epistaxis will be compared to baseline using the Patient-Reported Outcome of cumulative weekly nose Bleeding Duration (PRO-CB). The PRO-CB association with biomarker variability over the duration of the study will be investigated. In the pilot study subjects will be treated with 2mg of sirolimus once daily to obtain a trough level of 6-10ng/ml for 3 months.

Official title: Sirolimus for Nosebleeds in HHT: A Phase II Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2022-03-16

Completion Date

2024-12-02

Last Updated

2026-06-04

Healthy Volunteers

No

Interventions

DRUG

Sirolimus

Oral sirolimus provided with starting dose of 2mg once daily, adjusted to maintain drug blood levels of 6-10 ng/ml (3-month course)

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada