Could a lung fibrosis drug stop nosebleeds in HHT?
NCT ID NCT04976036
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Telangiectasia, hereditary hemorrhagic are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
COMPLETEDLausanne, Canton of Vaud, 1011, Switzerland
-
Clermont-Ferrand university hospital
RECRUITINGClermont-Ferrand, 63000, France
-
Lyon University Hospital, Dpt of genetics
RECRUITINGBron, 69677, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.