Intranasal Bevacizumab for HHT-Related Epistaxis

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT02389959
Phase
PHASE4
Status
Completed

Conditions

  • Epistaxis
  • HHT
  • Hereditary Hemorrhagic Telangiectasia
  • Nasal Bleeding
  • Nose Bleeds

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab will be mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL) will be injected into each side of the nose
  • Placebo (Saline) — DRUG
    4mL of saline will be mixed by the Stanford Hospital Pharmacy as a control

Study Details

This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis when used in conjunction with bipolar electrocautery.

Key Dates

First listed
Mar 17, 2015
Start date
Aug 4, 2014
Status verified
Aug 2021
Primary completion
Jan 23, 2020
Completion
Jan 23, 2020

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    The Stanford Hospital Investigational Pharmacy will perform all randomization, drug storage and management, as well as mixing and packaging for double-blinded injection of bevacizumab or saline control. Patients will undergo standard-of-care bipolar electrocautery of nasal telangiectasias in the Stanford Surgery Center operating room. At the time of electrocautery, patients will receive intranasal injection of either study drug or saline control. The surgeon performing the injection will be blinded to whether injection is composed of bevacizumab or saline control. Bevacizumab will be mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL) will be injected into each side of the nose. Injections will be performed according to the standardized four-point injection protocol (0.5mL/site) based on the vascular anatomy of the nose published in 2012 by Dheyauldeen et al.
  • Placebo Comparator: Saline Control
    The Stanford Hospital Investigational Pharmacy will perform all randomization, drug storage and management, as well as mixing and packaging for double-blinded injection of bevacizumab or saline control. Patients will undergo standard-of-care bipolar electrocautery of nasal telangiectasias in the Stanford Surgery Center operating room. At the time of electrocautery, patients will receive intranasal injection of either study drug or saline control. The surgeon performing the injection will be blinded to whether injection is composed of bevacizumab or saline control. The saline control placebo will be mixed by the Stanford Hospital Pharmacy to a total dose of 4mL in order to be identical in quantity and appearance to the mixed doses of bevacizumab, and 2mL will be injected into each side of the nose. Injections will be performed according to the standardized four-point injection protocol (0.5mL/site) based on the vascular anatomy of the nose published in 2012 by Dheyauldeen et al.

Primary Outcome Measure

Change in Epistaxis Severity Score (ESS) [ Time Frame: Baseline and month 1, month 2, month 4, month 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Department of Otolaryngology- Head and Neck SurgeryStanfordCalifornia94305-

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Stanford University Department of Otolaryngology- Head and Neck Surgery· Stanford, CA

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