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NCT05987449 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
A Phase 1 study of Hemophilia A, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 13
- Study locations
NCT05987449 is a Phase 1 study of Hemophilia A that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 60 participants, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (33% lower). The trial reports 13 study locations across 9 states.
The verdict
NCT05987449, a Phase 1 study of Hemophilia A, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 13
- Study locations
Study Summary
WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: * Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors. * Part 2 is a multiple-dose study in pediatric male participants with severe or moderate hemophilia A with or without FVIII inhibitors. The overall aim of the study is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of NXT007.
Conditions Studied
Interventions
- DRUG NXT007
Study Locations (13)
Other
- Auckland Cancer Trial Centre - Auckland
- Uniwersyteckie Centrum Kliniczne - Gda?sk
- Instytut Hematologii i Transfuzjologii - Warsaw
- Hospital Universitario la Paz - Madrid
- Hospital Regional Universitario Carlos Haya - Málaga
California
- UC Davis Cancer Center - Sacramento
District of Columbia
- Georgetown Uni Medical Center - Washington D.C.
Indiana
- Indiana Hemophilia & Thrombosis center - Indianapolis
Iowa
- University of Iowa Hospitals and Clnics Dept of Pediatrics - Iowa City
British Columbia
- British Columbia Children's Hospital - Vancouver
Ontario
- Hamilton Health Sciences Corporation - Hamilton
Lombardy
- Istituto Clinico Humanitas - Rozzano (MI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2030-06-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05987449
The ClinicalTrials.gov registry entry for NCT05987449 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (33% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which NXT007 is the first listed.
NCT05987449 reports 13 study locations spanning 9 distinct geographic areas - top geographies include Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05987449 about?
NCT05987449 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A". WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: * Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors. * Part 2 is a mult...
What is the current status of trial NCT05987449?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-09-21. Estimated completion is 2030-06-16.
What conditions does trial NCT05987449 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT05987449?
The interventions under investigation include: NXT007 (DRUG).
Who is sponsoring clinical trial NCT05987449?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05987449 being conducted?
This trial has 13 study locations across California, District of Columbia, Indiana, Iowa, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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