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New drug aims to stop nosebleeds in rare genetic disorder

NCT ID NCT05406362

Disease control Sponsor: Vaderis Therapeutics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called VAD044 in 75 adults with hereditary hemorrhagic telangiectasia (HHT), a condition that causes frequent nosebleeds and anemia. The first part compares two doses of VAD044 against a placebo to see if it safely reduces the number, length, and severity of nosebleeds. The second part is an open-label extension to check long-term safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

75 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For Part I of the study: Inclusion Criteria: * Diagnosis of HHT by the Curaçao criteria * Several epistaxis/week * Anaemia * COVID-19 vaccination or positive COVID-19 antibody test * Patient has given written informed consent to participate in Part I Exclusion Criteria: * Type 1 diabetes or uncontrolled type II diabetes (insulin or non-insulin dependent) * Active COVID-19 infection * active uncontrolled infection or known to be serologically positive for HIV, Hep B, Hep C infection * Recent procedures on nasal telangiectases (\<6 weeks) * Requiring therapeutic anticoagulation * Use of drugs with anti-angiogenic properties in the past 8 weeks * laboratory abnormalities Fort Part II of the study: Inclusion Criteria: * Completion of Part I of the study * All adverse events or serious adverse events occuring during Part I of the study have resolved * Patient has given written informed consent to participate in Part II Exclusion Criteria: \- Same as in Part I.

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Conditions

The condition(s) this trial relates to.

arteriovenous hemangioma/malformation hereditary hemorrhagic telangiectasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary hemorrhagic telangiectasia (HHT)

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Lyon, France

  • Hospital Universiati De Bellvitge

    Barcelona, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Ospedale Maggiore di Crema

    Crema, Italy

  • St. Antonius Hospital

    Nieuwegein, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

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