Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) (TAHHT)

This study has been completed.
Sponsor:
Collaborators:
Pharmacia GmbH, Erlangen, Germany
Baxter Healthcare Corporation
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01031992
First received: December 11, 2009
Last updated: December 12, 2009
Last verified: December 2009

December 11, 2009
December 12, 2009
March 2002
August 2002   (final data collection date for primary outcome measure)
Change of hemoglobin level within the phases. [ Time Frame: Beginning and end of each 3 months period. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01031992 on ClinicalTrials.gov Archive Site
Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) [ Time Frame: Measured once a day during each 3 months period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hereditary Hemorrhagic Telangiectasia
  • Drug: Tranexamic acid first, than placebo
    For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
  • Drug: First placebo, than Tranexamic acid.
    First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.
  • Experimental: Group I
    First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
    Intervention: Drug: Tranexamic acid first, than placebo
  • Experimental: Group II
    First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).
    Intervention: Drug: First placebo, than Tranexamic acid.
Geisthoff UW, Seyfert UT, Kübler M, Bieg B, Plinkert PK, König 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. PubMed PMID: 25005464. .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
October 2002
August 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01031992
TAHHT, 141CHC9008-001
Yes
Universitätskliniken des Saarlandes
University Hospital, Saarland
  • Pharmacia GmbH, Erlangen, Germany
  • Baxter Healthcare Corporation
Principal Investigator: Urban W Geisthoff, Priv.-Doz. Dr.med. Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne
University Hospital, Saarland
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP