Topical Bevacizumab for the Management of Recurrent Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

NCT01397695 | Completed Phase 2 Results DMC

• 1 other identifier: 090666
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Terence M. Davidson, MD is conducting a research study to find out more about the topical application of Avastin (proper chemical name is bevacizumab) in the treatment of epistaxis (nose bleeding) in patients with Hereditary Hemorrhagic Telangiectasia (HHT).

Conditions

Hereditary Hemorrhagic Telangiectasia (HHT)

Outcome Measures

Primary Outcomes (1)

• Measurement of Epistaxis in Patients With HHT as Measured by the HHT Foundation Epistaxis Severity Score, Hematocrit, Hemoglobin and Serum Ferritin Levels.

  The Responsible Party for this record has passed away in 2013. There are no study team members still associated with this study at the institution. There have been no publications, and the study data cannot be located.

  1-2 years

Study Arms (1)

bevacizumab

EXPERIMENTAL

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.

bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over the age of 18
• Both male and non-pregnant females adults capable of making informed consent who have HHT by Curacao criteria and whose nasal bleeding due to HHT is of such a magnitude that it requires medical care
• Additionally, females of childbearing age will be given a pregnancy test as a preliminary measure to ensure that those who become involved are not at risk.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Research Compliance and Integrity
• Organization: UCSD

ctgov@ucsd.edu

(858) 822-4939

Study Officials

• Terence Davidson, M.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: June 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (1)