The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT01507480
• Date of registration: 06/12/2011
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia ELLIPSE
• Scientific title: The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia.
• Date of first enrolment: October 2011
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01507480
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Frederic FAURE, MD
• Affiliation: Hospices Civils de Lyon

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years.

- Patients who give voluntary, informed consent and sign a consent form.

- Patients affiliated with the French universal health care system.

- Patients treated for HHT, that has been confirmed clinically (presence of at lease 3
Curaçao criteria) and/or by molecular biology.

- Patients who fill out epistaxis tally sheets completely in the three months before
inclusion.

- Patients who present severe epistaxis averaging over 30 minutes in the three months
before inclusion ((duration M1 + duration M2 + duration M3) / 3).

- Patients whose number of red blood cell transfusions in the six months before
inclusion is known.

- Patients who have not undergone nasal surgery in the three months before inclusion.

Exclusion Criteria:

- Pregnant women or women who could become pregnant during the study.

- Patients not affiliated with the French universal health care system.

- Patients who are protected adults according to the terms of the law (French public
health laws).

- Refusal to give consent.

- Patients whose HHT diagnosis has not be confirmed clinically and/or by molecular
biology.

- Infectious episode.

- Patients presenting unchecked hypertension at the time of inclusion (systolic BP > 150
mmHg and/or diastolic BP > 100 mmHg) with or without treatment. -Patients with
hypertension can be included, once blood pressure levels have been controlled by
appropriate medical treatment.

- Participation in another therapeutic trial in the 28 days before inclusion. Patients
who have already being treated with bevacizumab by intravenous infusion.

- A known hypersensitivity to the active substance or one of its excipients.A known
hypersensitivity to products containing Chinese hamster ovarian (CHO) cells or to
other human or humanized recombinant antibodies.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Telangiectasia, Hereditary Hemorrhagic

Rendu Osler Disease

Intervention(s)

Drug: Bevacizumab

Primary Outcome(s)

Tolerance [Time Frame: 3 months]

Secondary Outcome(s)

Systemic passage and pharmacokinetics [Time Frame: 3 months]

Efficacy [Time Frame: 3 months]

Secondary ID(s)

2010-650

Source(s) of Monetary Support

Please refer to primary and secondary sponsors