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NCT03370172 · ClinicalTrials.gov registry record · Phase 1
A Study of BAX 888 in Male Adults With Severe Hemophilia A
A Phase 1 study of Hemophilia A, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 20
- Study locations
NCT03370172: Completed Phase 1 study of Hemophilia A, sponsored by Baxalta now part of Shire.
NCT03370172 is a Phase 1 study of Hemophilia A that has completed, run by Baxalta now part of Shire. The registered enrollment target is 4 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03370172, a Phase 1 study of Hemophilia A, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults. Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A Serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. AEs include both serious and non-serious adverse events including development of
Conditions Studied
Interventions
- DRUG BAX 888
Study Locations (20)
California
- Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center - Los Angeles
- UC Davis Medical Center - Sacramento
Other
- AKH - Medizinische Universität Wien - Vienna
- Vivantes Klinikum im Friedrichshain - Berlin
Arizona
- Phoenix Childrens Hospital - Phoenix
Colorado
- University of Colorado Hemophilia & Thrombosis Center - Aurora
New York
- Mount Sinai Medical Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
South Carolina
- Medical University of South Carolina (MUSC) - Charleston
Texas
- Gulf States Hemophilia and Thrombophilia Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 1 |
What the finished NCT03370172 record still lists
NCT03370172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which BAX 888 is the first listed.
NCT03370172 names 20 study sites across 18 states, led by California, Other, Arizona.
Frequently Asked Questions
What is clinical trial NCT03370172 about?
NCT03370172 is a clinical study titled "A Study of BAX 888 in Male Adults With Severe Hemophilia A". The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults. Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their...
What is the current status of trial NCT03370172?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2018-02-27. Estimated completion is 2024-07-09.
What conditions does trial NCT03370172 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT03370172?
The interventions under investigation include: BAX 888 (DRUG).
Who is sponsoring clinical trial NCT03370172?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03370172 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03370172's enrollment target sits among peer trials
4 42nd of 42 higher than 1 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A 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.
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