WithdrawnNot Applicable

Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography

Stopped: Study never opened.

0Started 2017-01

Plain-language summary

This pilot study will investigate the use of thromboelastograph (TEG) to determine the primary bypassing agent for the management of bleeding in children and adults severe hemophilia A patients with inhibitors. The study will evaluate the TEG profile for each of the available bypassing agents (FEIBA and rFVIIa) in each participating patient, which will then determine which agent provides the most robust clot formation as measured by the TEG. This study will consist of screening visit and 2-4 pharmacokinetic studies to determine the "best" bypassing agent based on the TEG results. Patients will then be assigned that bypassing agent and dose for the treatment of their bleeding episodes (Prophylaxis or On-demand). Each patient will be then followed for a period of 6 months to monitor short-term safety of those patients whose bypassing agent was modified.

Who can participate

Age range4 Years – 70 Years

SexMALE

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Inclusion criteria

✓. Males, 4-60 years old, inclusive on Prophylaxis or On-Demand treatment
✓. Diagnosis of Hemophilia with active titer inhibitors (\> 0.6 BU)
✓. Willing to alter their treatment regimen per study protocol

Exclusion criteria

✕. Bleeding disorder(s) other than hemophilia A with inhibitors
✕. Thrombocytopenia (platelet count \<100,000K/µL)
✕. Any concurrent clinically significant major disease that, in the opinion of the investigator, would make the subject unsuitable for enrollment
✕. Participation within the past 30 days in a clinical study involving investigational drugs
✕. Planned major surgery within 30 days prior to screening or during the study period

What they're measuring

Elastic properties of a forming clot using thromboelastograph to determine best bypassing agent

Timeframe: 6 months

Trial details

NCT IDNCT03002480

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Hemophilia a with Inhibitors trials