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Immunosuppressant

Tacrolimus for Hereditary Hemorrhagic Telangiectasia

Phase 2
Waitlist Available
Led By Marie E Faughnan, MD,MSc,FRCPC
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Clinical HHT diagnosis or personal genetic diagnosis of HHT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks; 12,18,24,30,36,42,48,60,66,72,78,84,96
Awards & highlights

Study Summary

This trial will investigate whether tacrolimus can reduce epistaxis severity in HHT subjects. If successful, the drug could be used to treat HHT patients with recurrent nosebleeds.

Who is the study for?
This trial is for adults over 18 with Hereditary Hemorrhagic Telangiectasia (HHT) who suffer from frequent nosebleeds, at least 15 minutes per week. Participants must have a clinical or genetic diagnosis of HHT and at least one visible telangiectasia. Pregnant or breastfeeding women, those not using effective contraception, people with certain allergies, acute infections, high creatinine levels, liver issues, abnormal ECGs or unstable illnesses cannot join.Check my eligibility
What is being tested?
The study tests if low-dose tacrolimus capsules taken orally can reduce the severity of nosebleeds in HHT patients. It will also look for changes in vascular malformations and biomarkers related to HHT in blood and tissue. This Phase II trial involves giving subjects the drug twice daily for six months.See study design
What are the potential side effects?
Tacrolimus may cause side effects such as increased risk of infection due to immune system suppression, kidney problems reflected by elevated creatinine levels, potential liver dysfunction indicated by raised transaminase levels (AST/ALT), and possible heart rhythm abnormalities detectable on an ECG.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with HHT either through clinical evaluation or genetic testing.
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I have nosebleeds lasting 15 minutes or more each week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks; 12,18,24,30,36,42,48,60,66,72,78,84,96
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks; 12,18,24,30,36,42,48,60,66,72,78,84,96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in epistaxis (nose bleeding) severity using low-dose Tacrolimus
Secondary outcome measures
Change in Biomarkers
Change in Chronic Bleeding
Change in Epistaxis Severity Score (ESS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tacrolimus immediate-release capsulesExperimental Treatment1 Intervention
subjects will be treated with a 6 months course of oral low-dose tacrolimus capsules to be taken twice daily starting dose of 0.025 mg/kg/day, adjusted to maintain drug blood levels of 2-5ng/ml

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
537 Previous Clinical Trials
447,509 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,164 Total Patients Enrolled
Marie E Faughnan, MD,MSc,FRCPCPrincipal InvestigatorUnity Health Toronto

Media Library

Tacrolimus (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04646356 — Phase 2
Osler-Weber-Rendu Syndrome Research Study Groups: Tacrolimus immediate-release capsules
Osler-Weber-Rendu Syndrome Clinical Trial 2023: Tacrolimus Highlights & Side Effects. Trial Name: NCT04646356 — Phase 2
Tacrolimus (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646356 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research is available regarding the use of low-dosage Tacrolimus capsule?

"At present, 150 clinical studies are in progress to assess the efficacy of Tacrolimus capsule (low-dose), with 18 trials reaching Phase 3. Most research sites for this medication are located in Nashville, Tennessee; however across 871 locations there is currently ongoing testing for Tacrolimus capsule (low-dose)."

Answered by AI

How is Tacrolimus capsule (low-dose) usually employed therapeutically?

"The tacrolimus capsule (low-dose) is most often utilized to help patients with dermatitis and atopic conditions. Additionally, it may be beneficial in addressing liver or kidney transplant rejection as well as psoriasis."

Answered by AI

Are participants still being welcomed to join this experiment?

"Clinicaltrials.gov attests that this medical trial is still enrolling patients, with its initial posting having been on October 20th 2020 and the most recent edit to the page being from November 10th 2022."

Answered by AI

What potential risks accompany ingestion of low-dose Tacrolimus capsules?

"Although limited clinical data exists attesting to the efficacy of tacrolimus capsules (low-dose), there is some evidence that it can be safe, resulting in a safety rating of 2."

Answered by AI

How many participants are currently enrolled in this experiment?

"Affirmative. As indicated by clinicaltrials.gov, this trial is actively recruiting patients since its launch on October 20th 2020 and most recent update occurring November 10th 2022. 30 individuals are being sought after across 1 location."

Answered by AI
~7 spots leftby Apr 2025