North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Part of paid clinical trials in Los Angeles, California.

Sponsor
James Gossage
Study ID
NCT01408030
Phase
PHASE2
Status
Completed

Conditions

  • Epistaxis
  • Telangiectasia, Hereditary Hemorrhagic

Eligibility Criteria

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

Interventions

  • Sterile saline — DRUG
    0.9%, 0.1 ml spray in each nostril bid
  • Bevacizumab — DRUG
    1% solution in saline, 0.1 ml spray in each nostril bid
  • Estriol — DRUG
    0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
  • Tranexamic Acid — DRUG
    10% solution in saline, 0.1 ml spray in each nostril bid

Study Details

The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment of HHT related nosebleeds.

Key Dates

First listed
Aug 2, 2011
Start date
Aug 31, 2011
Status verified
Oct 2018
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

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

Arms

  • Placebo Comparator: Placebo spray
    sterile saline
  • Active Comparator: Bevacizumab spray
    bevacizumab 1%
  • Active Comparator: Estriol spray
    Estriol 0.1%
  • Active Comparator: Tranexamic acid spray
    tranexamic acid 10%

Primary Outcome Measure

Frequency of Epistaxis [ Time Frame: Weeks 5-12 of active treatment phase ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
Georgia Regents UniversityAugustaGeorgia30912-
Johns Hopkins UniversityBaltimoreMaryland21205-
Washington University School of MedicineSt LouisMissouri63110-
Oregon Health Sciences UniversityPortlandOregon97239-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CAGeorgia Regents University· Augusta, GAJohns Hopkins University· Baltimore, MDWashington University School of Medicine· St Louis, MOOregon Health Sciences University· Portland, ORUniversity of Utah· Salt Lake City, UT

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