Trial reportmAbs
ELLIPSE Study: a Phase 1 study evaluating the tolerance of bevacizumab nasal spray in the treatment of epistaxis in hereditary hemorrhagic telangiectasia.
Trial report in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01507480 (The ELLIPSE Study), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia.
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Treatments of Epistaxis in Hereditary Hemorrhagic Telangiectasia: Systematic Review and Network Meta-Analysis.Current allergy and asthma reports · 2023Pooled it
- Meta-analysis of efficacy and safety of bevacizumab in the treatment of hereditary hemorrhagic telangiectasia epistaxis.Frontiers in pharmacology · 2023Pooled it
- Efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. A double-blind, randomized, placebo-controlled trial.Scientific reports · 2019Trial
- Efficacy and safety of thalidomide for the treatment of severe recurrent epistaxis in hereditary haemorrhagic telangiectasia: results of a non-randomised, single-centre, phase 2 study.The Lancet. Haematology · 2015Trial
- Epistaxis Prevention, Treatment, and Future Perspectives for Hereditary Hemorrhagic Telangiectasia.Journal of clinical medicine · 2025Review
- Clinical Efficacy and Safety of Intralesional Bevacizumab in Dermatology: Insights from a Systematic Review.Dermatology practical & conceptual · 2025Review
- The Adverse Effects and Use of Bevacizumab in Patients with Glioblastoma: A Systematic Review and Meta-Analysis.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Hereditary hemorrhagic telangiectasia: from signaling insights to therapeutic advances.The Journal of clinical investigation · 2024Review
- Silicone septal splint for recurrent epistaxis in HHT patients: experience of a national referral centre.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2023Article
- Inhalation monoclonal antibody therapy: a new way to treat and manage respiratory infections.Applied microbiology and biotechnology · 2021Review
- Endoscopic surgical treatment of epistaxis in hereditary haemorrhagic telangiectasia: our experience.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2021Article
- Review of Pharmacological Strategies with Repurposed Drugs for Hereditary Hemorrhagic Telangiectasia Related Bleeding.Journal of clinical medicine · 2020Review
- Risk factors for hemorrhage of brain arteriovenous malformation.CNS neuroscience & therapeutics · 2019Review
- Intranasal bevacizumab treatment on epistaxis in hereditary haemorrhagic telangiectasia: a case report.European journal of hospital pharmacy : science and practice · 2019Article
- Hereditary hemorrhagic telangiectasia: diagnosis and management from the hematologist's perspective.Haematologica · 2018Review
- Diagnosis and Treatment of Hereditary Hemorrhagic Telangiectasia.Ochsner journal · 2017Review
- Bevacizumab to Treat Cholangiopathy in Hereditary Hemorrhagic Telangiectasia: Be Cautious: A Case Report.Medicine · 2015Article
- Circulatory contributors to the phenotype in hereditary hemorrhagic telangiectasia.Frontiers in genetics · 2015Article
- Pericytes as targets in hereditary hemorrhagic telangiectasia.Frontiers in genetics · 2015Review
- Anti-angiogenic therapeutic strategies in hereditary hemorrhagic telangiectasia.Frontiers in genetics · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHereditary hemorrhagic telangiectasia (HHT) is a dominantly inherited genetic vascular disorder in which epistaxis is the most frequent manifestation, responsible for high morbidity. Management of this symptom has no standard, and local treatments are often aggressive. Their efficacy is variable and has not been proven. Anti-angiogenic drugs, such as bevacizumab, are a new treatment strategy. Its systemic administration in patients with HHT improves liver damage-related symptoms and epistaxis. To limit the systemic adverse effects of bevacizumab and to ease administration, a local administration seems suitable. PRIMARY
objectiveTo evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis. Secondary objectives were to study the bioavailability and efficacy of bevacizumab against epistaxis when given as a nasal spray. METHODOLOGY: Phase 1, randomized, double-blind, placebo-controlled, monocentric study performed sequentially (dose escalation) on 5 groups of 8 patients. Each group was made up of 6 verum and 2 placebos. Five increasing doses of bevacizumab nasal spray (25 mg/mL) were evaluated: 12.5, 25, 50, 75 and 100 mg.
resultsA total of 40 patients were included between October 2011 and October 2012. Bevacizumab nasal spray was well tolerated in all patients and the drug was not detected in their serum. No dose limiting toxicity was observed. No efficacy was observed at any dose in this study.
conclusionBased on these results, bevacizumab nasal spray is a safe treatment of epistaxis in HHT. However, a randomized Phase 2 study is needed to determine its efficacy.
trial registrationClinicalTrials.gov Identifier #NCT01507480.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.