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Study on efficacy of nintedanib for treatment of epistaxis in hereditary haemorrhagic telangiectasia (HHT) patients - EPISTOP
EU CTIS ID: 2024-518886-89-00
What this study is testing
Whether the proportion of HHT patients with a reduction of at least 30% of epistaxis duration after 16 weeks of study treatment compared to baseline, is significantly higher in patients treated with nintedanib than in patients treated with placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent
- 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 criteria2 )
- Aged ≥18 years at the time of informed consent
- Moderate to serious epistaxis (Epistaxis Severity Score ESS≥2.5)
- Absence of cerebral arteriovenous malformation demonstrated by brain imaging
You likely can't join if
- Women who are pregnant or breastfeeding because of the potential dangerous effect of the treatment on the fetus or infant
- Any other serious underlying medical condition that could interfere with study treatment and potential adverse events
- Any mental or other impairment that may compromise compliance with the study requirements.
- Pregnant woman or woman of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to trial and/or committing to using it until 3 months after the end of treatment.
- Acute infection
- AST or ALT or ALKP or GGT or total bilirubin >1.5x (or >2.5x in patients known for Gilbert’s syndrome) the upper limit of normal
See the full eligibility criteria
- Signed informed consent
- 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 criteria2 )
- Aged ≥18 years at the time of informed consent
- Moderate to serious epistaxis (Epistaxis Severity Score ESS≥2.5)
- Absence of cerebral arteriovenous malformation demonstrated by brain imaging
- Women who are pregnant or breastfeeding because of the potential dangerous effect of the treatment on the fetus or infant
- Any other serious underlying medical condition that could interfere with study treatment and potential adverse events
- Any mental or other impairment that may compromise compliance with the study requirements.
- Pregnant woman or woman of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to trial and/or committing to using it until 3 months after the end of treatment.
- Acute infection
- AST or ALT or ALKP or GGT or total bilirubin >1.5x (or >2.5x in patients known for Gilbert’s syndrome) the upper limit of normal
- Renal clearance by Cockcroft-Gault formula <30 ml/min
- Untreated pulmonary arteriovenous malformation
- Hemoptysis or hematuria within the last 12 months
- Ulcus or active gastric bleeding within the last 12 months
- Anticoagulant or antiplatelets treatment
- Coronary heart disease
- Participation in another interventional clinical trial which may interfere with the proposal trial (judgment of the investigator)
- Thrombotic event within the last 12 months
- Long QT syndrome (on ECG performed at screening)
- Known allergy to Nintenanib, soya, peanuts
- Bevacizumab, pazopanib or other anti-angiogenic treatments within the last 12 months
- Concomitant treatment with ketoconazole, erythromycin, rifampicin, carbamazepine, phenytoin, St John’s Wort
- Surgery within the last 3 months or planned within the next 9 months
- Recent unhealed wound
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.