Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)
Recruiting
Phase 2
Interventional Study
Glanzmann Thrombasthenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 6 (estimated)
- Sponsor
- Emory University · Other
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About This Trial
This study is evaluating an investigational drug, eptacog beta (EB), for the treatment and prevention of acute bleeding episodes in people with Glanzmann Thrombasthenia, a rare inherited bleeding disorder. Eptacog beta (EB) is not currently approved by the U.S. Food and Drug Administration (FDA) for this condition.
The study will assess the effectiveness and safety of eptacog beta (EB) when used …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult or Pediatric persons with inherited Glanzmann thrombasthenia (see diagnostic criteria below)
* Severe bleeding phenotype
* Adequate hepatic function
* Adequate renal function
* Adults subject (≥18 years of age) or caregiver (parent or legally authorized representative) f…
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