- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01507480
The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia (ELLIPSE)
The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia.
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 symptoms and epistaxis (cases reported and on-going study-ClinicalTrials.gov Identifier #NCT00843440-). To limit the systemic adverse effects of bevacizumab and to ease administration, a local administration seems suitable.
A clinical case recently showed the benefits of bevacizumab nasal spray in these patients. Its results were confirmed in a characterization study on bevacizumab transport through porcine nasal mucosa (in press).
It seems necessary to assess the tolerance and efficacy of bevacizumab nasal spray in humans for the treatment of epistaxis in HHT with a prospective phase 1 study.
The primary objective of the study is to evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.
This phase-1, randomized, double-blind, placebo-controlled, monocentric study is to be carried out sequentially (dose escalation) on 5 groups of 8 patients. Each group is made up of 6 verum and 2 placebos.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab
This study is to be carried out sequentially (dose escalation) on 5 groups of 8 patients.
Each group is made up of 6 verum and 2 placebos.
|
There are five increasing doses of bevacizumab nasal spray (25mg/mL): 10 mg, 25 mg, 50 mg, 75, mg and 100 mg.
Each test dose is a single dose divided into five fractions and administered into each nostril every 30 minutes for 2 hours:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance
Time Frame: 3 months
|
Evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic passage and pharmacokinetics
Time Frame: 3 months
|
Study the systemic passage and pharmacokinetics of bevacizumab in these patients.
|
3 months
|
Efficacy
Time Frame: 3 months
|
Evaluate the efficacy of bevacizumab nasal spray on the appearance of epistaxis (number, frequency)
|
3 months
|
Efficacy
Time Frame: 3 months
|
Evaluate the efficacy of bevacizumab nasal spray on hemoglobinema and ferritin
|
3 months
|
Efficacy
Time Frame: 3 months
|
Evaluate the efficacy of bevacizumab nasal spray on the number of red blood cell transfusions
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frederic FAURE, MD, Hospices Civils de Lyon
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Otorhinolaryngologic Diseases
- Hemostatic Disorders
- Signs and Symptoms, Respiratory
- Nose Diseases
- Cardiovascular Abnormalities
- Vascular Malformations
- Epistaxis
- Telangiectasis
- Telangiectasia, Hereditary Hemorrhagic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- 2010-650
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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