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NCT07136857 · ClinicalTrials.gov registry record · Phase 2

Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)

A Phase 2 study of Glanzmann Thrombasthenia, sponsored by Emory University.

Recruiting
Registry status
Phase 2
Development phase
6
Enrollment target
1
Study location

NCT07136857: Recruiting Phase 2 study of Glanzmann Thrombasthenia, sponsored by Emory University.

NCT07136857 is a Phase 2 study of Glanzmann Thrombasthenia that is actively recruiting participants, run by Emory University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07136857, a Phase 2 study of Glanzmann Thrombasthenia, is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 2
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

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 to treat serious bleeding events, and in an optional phase, when used routinely to prevent bleeding. During the first three (3) months, participants will manage any bleeding episodes with their standard treatment (e.g., factor products or platelet transfusions). After this initial period, they will use the study drug to treat serious bleeding events. Participants will have approximately 4 to 5 visits with their hematologist over the 9-month study period. They will also be asked to complete a diary documenting bleeding episodes and treatments, and to answer questions about how bleeding affects their daily life. Blood samples will be collected to monitor their condition and any potential side effects of the study drug. At the end of the main study, participants will have the option to enter an optional extension phase, where they will receive routine intravenous infusions of the study drug 2 to 3 times per week for 6 months to help prevent future bleeding episodes and complications.

Primary Outcome

Proportion of acute bleeding events successfully treated with EB within 24 hours of the first EB administration based on an "excellent or good" response on a 4-point hemostatic efficacy scale and without rebleeding before 36 hours. Hemostatic Efficacy Scale: None = No effect; bleeding unchanged or worsened; continued treatment needed. Moderate = Some effect (e.g., pain decreased, bleeding signs improved) but bleeding continued; further treatment needed. Good = Bleeding symptoms are largely r

Conditions Studied

Glanzmann Thrombasthenia

Interventions

  • DRUG EPTACOG BETA

Study Locations (1)

Georgia

  • Arthur M. Blank Hospital | Children's Healthcare of Atlanta - Atlanta

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2025-10-02
Est. Completion 2026-12
Phase Phase 2
Emory University

1,208 total trials

What NCT07136857 shows while recruiting

NCT07136857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Glanzmann Thrombasthenia appearing as the primary indexed condition, and to 1 intervention - of which EPTACOG BETA is the first listed.

NCT07136857 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT07136857 about?

NCT07136857 is a clinical study titled "Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)". 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...

What is the current status of trial NCT07136857?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2025-10-02. Estimated completion is 2026-12.

What conditions does trial NCT07136857 study?

This clinical trial studies the following conditions: Glanzmann Thrombasthenia.

What interventions are being tested in trial NCT07136857?

The interventions under investigation include: EPTACOG BETA (DRUG).

Who is sponsoring clinical trial NCT07136857?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07136857 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Where NCT07136857's enrollment target sits among peer trials

6 1997th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07136857

Source: ClinicalTrials.gov NCT07136857, the US trial registry maintained by the National Library of Medicine. NCT07136857 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.