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Could a lung fibrosis drug stop nosebleeds in HHT?

NCT ID NCT04976036

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether nintedanib, a drug already used for lung scarring, can reduce nosebleeds in people with hereditary hemorrhagic telangiectasia (HHT). About 48 adults with moderate to severe nosebleeds will take either nintedanib or a placebo twice daily for 16 weeks. The main goal is to see if the drug cuts monthly nosebleed time by at least 30% compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nintedanib
What this could lead to
If it works, this could provide a new treatment option to reduce the frequency and duration of nosebleeds in people with HHT.
What could go wrong
This is a small Phase 2 trial with only 48 participants, so results may not apply to everyone. Nintedanib can cause side effects like stomach issues, and it may not work better than placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion criteria: 1. signed informed consent 2. definite HHT disease (defined as the presence of a pathogenic mutation in one of the HHT genes, or the presence of 3 out of 4 Curaçao clinical criteria) 3. age ≥18 years at the time of informed consent 4. moderate to serious epistaxis defined as Epistaxis Severity Score (ESS) ≥2.5 5. absence of cerebral arteriovenous malformation demonstrated by brain imaging Exclusion criteria: 1. Women who are pregnant or breastfeeding 2. For women of childbearing potential (WOCBP, see Annex VII for definition), non-agreement to follow instructions for method(s) of contraception for the heterosexual couple (see Annex VII for instructions) during the treatment period and follow-up, or at least 3 months after the last dose of IMP, or if there are concerns that they will not reliably comply with the contraception requirements. 3. Acute infection 4. aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or total bilirubin \>1.5x (or \>2.5x in patients known for Gilbert's syndrome) the upper limit of normal 5. Renal clearance by Cockcroft-Gault formula \<30 ml/min 6. Untreated pulmonary arteriovenous malformation (if vaso-occlusion is technically feasible) 7. Hemoptysis or hematuria within the last 12 months 8. Ulcus or active gastric bleeding within the last 12 months 9. Anticoagulant or antiplatelets treatment 10. Coronary heart disease 11. Thrombotic event within the last 12 months 12. Long QT syndrome (on ECG performed at screening) 13. Known allergy to nintedanib, soya, peanuts 14. Bevacizumab, pazopanib or other anti-angiogenic treatments within the last 12 months 15. Concomitant treatment with ketoconazole, erythromycin, rifampicin, carbamazepine, phenytoin, St John's Wort 16. Surgery within the last 3 months or planned within the next 9 months 17. Recent unhealed wound 18. Any other serious underlying medical condition that could interfere with the study treatment and potential adverse events 19. Any mental or other impairment that may compromise compliance with the study requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Angiology Department, Lausanne University Hospital

    COMPLETED

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Clermont-Ferrand university hospital

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Lyon University Hospital, Dpt of genetics

    RECRUITING

    Bron, 69677, France

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