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Immunomodulatory Agent

Pomalidomide Oral Product for Hereditary Hemorrhagic Telangiectasia (HHT) (PATH-HHT Trial)

Phase 2

Waitlist Available

Led By Keith McCrae, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks, baseline to 12 weeks and baseline to 28 weeks

Awards & highlights

PATH-HHT Trial Summary

This trial is testing whether the drug pomalidomide can help treat people with a genetic condition that causes them to have excessive nosebleeds.

Eligible Conditions

Hereditary Hemorrhagic Telangiectasia (HHT)

PATH-HHT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks, baseline to 12 weeks and baseline to 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks, baseline to 12 weeks and baseline to 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks, baseline to 12 weeks and baseline to 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Epistaxis Severity Score

Secondary outcome measures

Amount of Packed red blood cell Transfusions

Amount of Parenteral Iron Administration

Change in HHT-Specific QOL

+2 more

Other outcome measures

Change in PROMIS Emotional Distress-Depression Short Form (V1.0)

Change in PROMIS Fatigue Short Form (V1.0)

Change in the Epistaxis Severity Score

+3 more

PATH-HHT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PomalidomideExperimental Treatment1 Intervention

Oral Pomalidomide will be provided as a capsule at 4 mg/day dose. There will be 6 treatment cycles of 28 days (4 weeks) each. Total treatment phase duration will be 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

A placebo matching the study drug will be provided as a capsule. There will be 6 treatment cycles of 28 days (4 weeks) each. Total treatment phase duration will be 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pomalidomide Oral Product

2019

Completed Phase 2

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,365,931 Total Patients Enrolled

RTI InternationalOTHER

188 Previous Clinical Trials

875,819 Total Patients Enrolled

Keith McCrae, MDPrincipal Investigator - The Cleveland Clinic

Cleveland Clinic Hospital

Duke University School Of Medicine (Medical School)

Duke University Medical Center (Residency)

5 Previous Clinical Trials

713 Total Patients Enrolled

Media Library

Pomalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03910244 — Phase 2

Hereditary Hemorrhagic Telangiectasia (HHT) Research Study Groups: Placebo, Pomalidomide

Hereditary Hemorrhagic Telangiectasia (HHT) Clinical Trial 2023: Pomalidomide Highlights & Side Effects. Trial Name: NCT03910244 — Phase 2

Pomalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03910244 — Phase 2

Frequently Asked Questions

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

Is this research endeavor currently open to new participants?

"Data on clinicaltrials.gov affirms that this trial is presently seeking participants, with the primary post being 10/17/2019 and the most recent edit occurring on 10/12/2022."

Answered by AI

How many individuals are involved in this medical experiment?

"That is accurate. Per publically available data on clinicaltrials.gov, this research project commenced recruiting patients on October 17th 2019 and is still open for candidates today. At present, 159 participants are being sought from 13 different medical facilities across the nation."

Answered by AI

Are there any previous investigations involving the Pomalidomide Oral Product?

"The medicinal potential of Pomalidomide Oral Product was first explored in 2010 at AOU Città della Salute e della Scienza di Torino - SC Ematologia U. Over the course of two decades, 236 clinical trials have been successfully completed, with 87 studies still ongoing across several locations including Cleveland, Ohio."

Answered by AI

Has the US Food and Drug Administration sanctioned Pomalidomide Oral Product?

"Despite lacking any evidence to suggest its efficacy, Pomalidomide Oral Product has been deemed safe enough with a score of 2."

Answered by AI

To what extent is this clinical trial being implemented across hospitals?

"This medical trial is mainly being conducted at Cleveland Clinic, University of Pennsylvania Perelman School of Medicine and the University of North carolina in Chapel Hill. Additionally, there are 13 other sites involved with this study."

Answered by AI

Recent research and studies

Frontiers in GeneticsJournal

Hereditary Hemorrhagic Telangiectasia: Genetics and Molecular Diagnostics in a New Era

McDonald, Jamie, Whitney Wooderchak-Donahue, Chad VanSant Webb, Kevin Whitehead, David A. Stevenson, and Pinar Bayrak-Toydemir. 2015. “Hereditary Hemorrhagic Telangiectasia: Genetics and Molecular Diagnostics in a New Era”. Frontiers in Genetics. Frontiers Media SA. doi:10.3389/fgene.2015.00001.

The LaryngoscopeJournal

An Epistaxis Severity Score for Hereditary Hemorrhagic Telangiectasia

Hoag, Jeffrey B., Peter Terry, Sally Mitchell, Douglas Reh, and Christian A. Merlo. 2010. “An Epistaxis Severity Score for Hereditary Hemorrhagic Telangiectasia”. The Laryngoscope. Wiley. doi:10.1002/lary.20818.

Thrombosis ResearchJournal

Depression and Post-traumatic Stress Disorder in Individuals with Hereditary Hemorrhagic Telangiectasia: A Cross-sectional Survey

Chaturvedi, Shruti, Marianne Clancy, Nicole Schaefer, Olalekan Oluwole, and Keith R. McCrae. 2017. “Depression and Post-traumatic Stress Disorder in Individuals with Hereditary Hemorrhagic Telangiectasia: A Cross-sectional Survey”. Thrombosis Research. Elsevier BV. doi:10.1016/j.thromres.2017.03.003.

The LaryngoscopeJournal