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

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ClinicalTrials.gov Identifier: NCT01397695
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Diego

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hereditary Hemorrhagic Telangiectasia (HHT)
Intervention Drug: Bevacizumab
Enrollment 20
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Bevacizumab
Hide Arm/Group Description Bevacizumab: 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.
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title Bevacizumab
Hide Arm/Group Description Bevacizumab: 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.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
1.Primary Outcome
Title Measurement of Epistaxis in Patients With HHT as Measured by the HHT Foundation Epistaxis Severity Score, Hematocrit, Hemoglobin and Serum Ferritin Levels.
Hide Description 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.
Time Frame 1-2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Bevacizumab: 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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description Bevacizumab: 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.
All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Compliance and Integrity
Organization: UCSD
Phone: (858) 822-4939
EMail: ctgov@ucsd.edu
Layout table for additonal information
Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT01397695     History of Changes
Other Study ID Numbers: 090666
First Submitted: July 18, 2011
First Posted: July 19, 2011
Results First Submitted: August 15, 2019
Results First Posted: September 5, 2019
Last Update Posted: September 5, 2019