NCT01031992

Brief Summary

Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with frequent nosebleeds in the majority of cases. Several reports in the literature support the use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the study are to test if Tranexamic acid taken orally can

  1. 1.improve anemia (lead to an increased hemoglobin level)
  2. 2.reduce nosebleeds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

December 11, 2009

Last Update Submit

December 12, 2009

Conditions

Hereditary Hemorrhagic Telangiectasia

Keywords

Hereditary hemorrhagic telangiectasiaRendu-Osler-Weber syndromeEpistaxisNosebleedsAnemiaTranexamic acidAntifibrinolytics

Outcome Measures

Primary Outcomes (1)

  • Change of hemoglobin level within the phases.

    Beginning and end of each 3 months period.

Secondary Outcomes (1)

  • Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)

    Measured once a day during each 3 months period

Study Arms (2)

Group I

EXPERIMENTAL

First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.

Drug: Tranexamic acid first, than placebo

Group II

EXPERIMENTAL

First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).

Drug: First placebo, than Tranexamic acid.

Interventions

Tranexamic acid first, than placeboDRUG

For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.

Group I
First placebo, than Tranexamic acid.DRUG

First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.

Group II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.

You may not qualify if:

  • pregnant,
  • minor,
  • had an increased risk of thrombotic events (history or signs of cerebrovascular events, cardiac arrhythmias, biochemically increased coagulation parameters),
  • renal insufficiency,
  • a history of massive hematuria or defects of color vision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätskliniken des Saarlandes, HNO-Abteilung

Homburg, Saarland, 66421, Germany

Location

Related Publications (1)

  • Geisthoff UW, Seyfert UT, Kubler M, Bieg B, Plinkert PK, Konig J. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study. Thromb Res. 2014 Sep;134(3):565-71. doi: 10.1016/j.thromres.2014.06.012. Epub 2014 Jun 16.

    PMID: 25005464DERIVED

MeSH Terms

Conditions

Telangiectasia, Hereditary HemorrhagicEpistaxisAnemia

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Urban W Geisthoff, Priv.-Doz. Dr.med.

    Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 15, 2009

Study Start

March 1, 2002

Primary Completion

August 1, 2002

Study Completion

October 1, 2002

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

DE(1)