Status:
COMPLETED
The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Rendu Osler Disease
Telangiectasia, Hereditary Hemorrhagic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Antiangiogenic drugs, such as bevacizumab, are a new treatment strategy in Hereditary Hemorrhagic Telangiectasia (HHT). Its systemic administration in patients with HHT improves liver damage-related s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01507480
Start Date
October 1 2011
End Date
December 1 2012
Last Update
October 19 2021
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