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NCT04567511 · ClinicalTrials.gov registry record · Phase 4

Hemlibra in Mild Hemophilia A

A Phase 4 study of Factor VIII Deficiency, Congenital, sponsored by Indiana Hemophilia &Thrombosis Center.

Recruiting
Registry status
Phase 4
Development phase
20
Enrollment target
1
Study location

NCT04567511: Recruiting Phase 4 study of Factor VIII Deficiency, Congenital, sponsored by Indiana Hemophilia &Thrombosis Center.

NCT04567511 is a Phase 4 study of Factor VIII Deficiency, Congenital that is actively recruiting participants, run by Indiana Hemophilia &Thrombosis Center. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% 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

NCT04567511, a Phase 4 study of Factor VIII Deficiency, Congenital, is actively recruiting participants, sponsored by Indiana Hemophilia &Thrombosis Center.

RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVIII activity of \>5% to 30%). The safety and hemostatic efficacy of Hemlibra (emicizumab) in this patient population will be investigated. Secondary outcomes will assess changes in joint health and quality of life in treated patients.

Primary Outcome

Change in FVIII human chromogenic activity, FVIII bovine chromogenic activity, and Thrombin Generation Assay relatively to one another

Interventions

  • DRUG Emicizumab

Study Locations (1)

Indiana

  • Indiana Hemophila @Thrombosis Center - Indianapolis

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-07-25
Est. Completion 2027-07
Phase Phase 4

What NCT04567511 shows while recruiting

NCT04567511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Factor VIII Deficiency, Congenital appearing as the primary indexed condition, and to 1 intervention - of which Emicizumab is the first listed.

NCT04567511 reports a single indexed study location in Indiana.

Frequently Asked Questions

What is clinical trial NCT04567511 about?

NCT04567511 is a clinical study titled "Hemlibra in Mild Hemophilia A". This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVI...

What is the current status of trial NCT04567511?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2022-07-25. Estimated completion is 2027-07.

What conditions does trial NCT04567511 study?

This clinical trial studies the following conditions: Factor VIII Deficiency, Congenital.

What interventions are being tested in trial NCT04567511?

The interventions under investigation include: Emicizumab (DRUG).

Who is sponsoring clinical trial NCT04567511?

This trial is sponsored by Indiana Hemophilia &Thrombosis Center, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04567511 being conducted?

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

How this trial's enrollment target compares

Where NCT04567511's enrollment target sits among peer trials

20 1753rd of 2000 higher than 168 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT04567511, the US trial registry maintained by the National Library of Medicine. NCT04567511 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.