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

NCT01408030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2018-10-19

Study results available
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Summary

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.

Conditions

  • Telangiectasia, Hereditary Hemorrhagic
  • Epistaxis

Interventions

DRUG

Sterile saline

0.9%, 0.1 ml spray in each nostril bid

DRUG

Bevacizumab

1% solution in saline, 0.1 ml spray in each nostril bid

DRUG

Estriol

0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid

DRUG

Tranexamic Acid

10% solution in saline, 0.1 ml spray in each nostril bid

Sponsors & Collaborators

  • HHT Foundation International

    collaborator UNKNOWN
  • James Gossage

    lead OTHER

Principal Investigators

  • James R Gossage, MD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408030 on ClinicalTrials.gov