The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia (ELLIPSE)
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|ClinicalTrials.gov Identifier: NCT01507480|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : May 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Hereditary Telangiectasia||Drug: Bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia.|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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 Name: AVASTIN
- Tolerance [ Time Frame: 3 months ]Evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.
- Systemic passage and pharmacokinetics [ Time Frame: 3 months ]Study the systemic passage and pharmacokinetics of bevacizumab in these patients.
- Efficacy [ Time Frame: 3 months ]Evaluate the efficacy of bevacizumab nasal spray on the appearance of epistaxis (number, frequency)
- Efficacy [ Time Frame: 3 months ]Evaluate the efficacy of bevacizumab nasal spray on hemoglobinema and ferritin
- Efficacy [ Time Frame: 3 months ]Evaluate the efficacy of bevacizumab nasal spray on the number of red blood cell transfusions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507480
|Principal Investigator:||Frederic FAURE, MD||Hospices Civils de Lyon|