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Tests treatment safety and results for Telangiectasia, Hereditary Hemorrhagic
Official title Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Patients
ClinicalTrials.gov ID: NCT04976036
What this study is testing
What is Nintedanib?
Nintedanib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for telangiectasia, hereditary hemorrhagic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients affected by hereditary hemorrhagic telangiectasia (HHT) very often suffer from recurrent nosebleeds called epistaxis. There is no treatment currently available to reduce the frequency or severity of epistaxis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- age ≥18 years at the time of informed consent
- moderate to serious epistaxis defined as 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
- For women of childbearing potential (WOCBP, see Annex VII for definition), non-agreement to follow instructions for method(s) of contraception for...
- Acute infection
- aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or total bilirubin \>1.5x (or \>2.5x in patients known for Gilbert's syndrome)...
- Renal clearance by Cockcroft-Gault formula \<30 ml/min
- Untreated pulmonary arteriovenous malformation (if vaso-occlusion is technically feasible)
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 criteria)
- age ≥18 years at the time of informed consent
- moderate to serious epistaxis defined as Epistaxis Severity Score (ESS) ≥2.5
- absence of cerebral arteriovenous malformation demonstrated by brain imaging
- Women who are pregnant or breastfeeding
- 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...
- Acute infection
- 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
- Renal clearance by Cockcroft-Gault formula \<30 ml/min
- Untreated pulmonary arteriovenous malformation (if vaso-occlusion is technically feasible)
- 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
- Thrombotic event within the last 12 months
- Long QT syndrome (on ECG performed at screening)
- Known allergy to nintedanib, 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
- Any other serious underlying medical condition that could interfere with the study treatment and potential adverse events
- Any mental or other impairment that may compromise compliance with the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Clermont-Ferrand, France
- Lausanne, Canton of Vaud, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Clermont-Ferrand, France; Lausanne, Canton of Vaud, 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 ClinicalTrials.gov; the study team decides eligibility.