Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Hereditary Hemorrhagic Telangiectasia Clinical Trial

— TAHHT  

Official title:

Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031992
• Other study ID #: TAHHT
• Secondary ID: 141CHC9008-001
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2009
• Last updated: December 12, 2009
• Start date: March 2002
• Est. completion date: October 2002

Study information

• Verified date: December 2009
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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. improve anemia (lead to an increased hemoglobin level)

2. reduce nosebleeds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hereditary Hemorrhagic Telangiectasia
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Drug:
• Tranexamic acid first, than placebo
For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
• First placebo, than Tranexamic acid.
First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.

Locations

Country	Name	City	State
Germany	Universitätskliniken des Saarlandes, HNO-Abteilung	Homburg	Saar

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Saarland	Baxter Healthcare Corporation, Pharmacia GmbH, Erlangen, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of hemoglobin level within the phases.		Beginning and end of each 3 months period.	No
Secondary	Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)		Measured once a day during each 3 months period	No