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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507480
First Posted: January 11, 2012
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
December 6, 2011
January 11, 2012
May 14, 2013
October 2011
December 2012   (Final data collection date for primary outcome measure)
Tolerance [ Time Frame: 3 months ]
Evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.
Same as current
Complete list of historical versions of study NCT01507480 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia
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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hemorrhagic Hereditary Telangiectasia
Drug: Bevacizumab
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
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.
Intervention: Drug: Bevacizumab
Dupuis-Girod S, Ambrun A, Decullier E, Samson G, Roux A, Fargeton AE, Rioufol C, Schwiertz V, Disant F, Chapuis F, Donazzolo Y, Paintaud G, Edery P, Faure F. ELLIPSE Study: a Phase 1 study evaluating the tolerance of bevacizumab nasal spray in the treatment of epistaxis in hereditary hemorrhagic telangiectasia. MAbs. 2014 May-Jun;6(3):794-9. doi: 10.4161/mabs.28025. Epub 2014 Jan 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
France
 
NCT01507480
2010-650
Yes
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Frederic FAURE, MD Hospices Civils de Lyon
Hospices Civils de Lyon
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP