Hereditary Hemorrhagic TelangiectasiaPhase 3TAHHTNCT01031992
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
A Phase 3 study of Hereditary Hemorrhagic Telangiectasia, run by University Hospital, Saarland at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Hemorrhagic Telangiectasia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2002to Oct 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätskliniken des Saarlandes, HNO-Abteilung
Homburg, Saarland, 66421
About this study
Official title: 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
- improve anemia (lead to an increased hemoglobin level)
- reduce nosebleeds.
- Conditions
- Hereditary Hemorrhagic Telangiectasia
- Being tested
- Tranexamic acid first, than placebo, First placebo, than Tranexamic acid.
- Keywords
- Hereditary hemorrhagic telangiectasia, Rendu-Osler-Weber syndrome, Epistaxis, Nosebleeds, Anemia, Tranexamic acid, Antifibrinolytics
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Epistaxis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid first, than placeboDrug
For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
First placebo, than Tranexamic acid.Drug
First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months. Receives: 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). Receives: Drug: First placebo, than Tranexamic acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hemoglobin level within the phases.
Measured: Beginning and end of each 3 months period.
Secondary outcomes (1)
Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)
Measured: Measured once a day during each 3 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startMar 2002
- Primary completionAug 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Hemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia GmbH, Erlangen, Germany, Baxter Healthcare Corporation
- Investigators
- Urban W Geisthoff, Priv.-Doz. Dr.med., Principal investigator, Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031992
- Sponsor's protocol ID
- TAHHT
- Other IDs
- 141CHC9008-001
- Acronym
- TAHHT
- Status last verified
- Dec 2009
- First submitted
- 11 Dec 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25005464
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia
- ClinicalTrials.gov ID
- NCT01031992
- Acronym / sponsor ID
- TAHHT / TAHHT
- Conditions
- Hereditary Hemorrhagic Telangiectasia
- Keywords
- Hereditary hemorrhagic telangiectasia, Rendu-Osler-Weber syndrome, Epistaxis, Nosebleeds, Anemia, Tranexamic acid, Antifibrinolytics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Collaborators
- Pharmacia GmbH, Erlangen, Germany, Baxter Healthcare Corporation
- Study start
- Mar 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- improve anemia (lead to an increased hemoglobin level)
- reduce nosebleeds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Tranexamic acid first, than placeboFirst verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months. |
| Group II | Experimental | Drug: First placebo, than Tranexamic acid.First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid first, than placeboFor 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months. | Drug | Group I |
| First placebo, than Tranexamic acid.First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months. | Drug | Group II |
Primary outcome
Change of hemoglobin level within the phases.
Time frame: Beginning and end of each 3 months period.
1 secondary outcome
Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)
Time frame: Measured once a day during each 3 months period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Derived from this study: PubMed 25005464Geisthoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urban W Geisthoff, Priv.-Doz. Dr.med. principal investigator
Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hereditary Hemorrhagic Telangiectasia, run by University Hospital, Saarland at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of hemoglobin level within the phases. (time frame: Beginning and end of each 3 months period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2009.