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NCT05181618 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
A Phase 4 study of Severe Hemophilia A and Moderate Hemophilia A, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 4
- Development phase
- 136
- Enrollment target
- 20
- Study locations
NCT05181618: Active Phase 4 study of Severe Hemophilia A and Moderate Hemophilia A, sponsored by Hoffmann-La Roche.
NCT05181618 is a Phase 4 study of Severe Hemophilia A and Moderate Hemophilia A that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 136 participants, above the 37-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (268% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05181618, a Phase 4 study of Severe Hemophilia A and Moderate Hemophilia A, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 136 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and \<70 years with severe hemophilia A without factor VIII (FVIII) inhibitors or moderate hemophilia A without FVIII inhibitors who are receiving FVIII prophylaxis and who will start emicizumab treatment as part of this study.
Conditions Studied
Interventions
- DRUG Emicizumab
Study Locations (20)
Other
- Charité Universitätsklinikum Berlin - Berlin
- Universitätsklinikum Bonn - Bonn
- Észak-Pesti Centrumkórház - Honvédkórház - Budapest
- Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique - Rabat
- University Clinical Centre of Serbia - Belgrade
- Complejo Hospitalario Universitario A Coruña (CHUAC) - A Coruña
- Hospital de la Santa Creu i Sant Pau - Barcelona
- Hospital Universitario Vall de Hebron - Barcelona
- Hospital Universitario la Paz - Madrid
- Hospital Regional Universitario Carlos Haya - Málaga
São Paulo
- Hospital das Clinicas - UNICAMP - Campinas
- Hospital das Clínicas Faculdades Médicas de Ribeirão Preto - Ribeirão Preto
California
- Orthopaedic Institute for Children - Los Angeles
Florida
- University of Miami Medical Center - Miami
Oklahoma
- Oklahoma Children's Hospital ? Jimmy Everest Center - Oklahoma City
Ontario
- Hamilton Health Sciences Corporation - Hamilton
Campania
- AOU Federico II - Naples
Lazio
- Policlinico Univ. A. Gemelli - Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2027-05-21 |
| Phase | Phase 4 |
What the registry record for NCT05181618 still lists
NCT05181618 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 37-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (268% higher).
The record links to 2 conditions, with Severe Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Emicizumab is the first listed.
NCT05181618 names 20 study sites across 10 states, led by Other, São Paulo, California.
Frequently Asked Questions
What is clinical trial NCT05181618 about?
NCT05181618 is a clinical study titled "A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis". Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and \<70 years with severe hemophilia A without factor VIII (FVIII) inhibitors or moder...
What is the current status of trial NCT05181618?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 136 participants. The study started on 2022-06-20. Estimated completion is 2027-05-21.
What conditions does trial NCT05181618 study?
This clinical trial studies the following conditions: Severe Hemophilia A, Moderate Hemophilia A.
What interventions are being tested in trial NCT05181618?
The interventions under investigation include: Emicizumab (DRUG).
Who is sponsoring clinical trial NCT05181618?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05181618 being conducted?
This trial has 20 study locations across California, Florida, Oklahoma, São Paulo, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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