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NCT02795767 · ClinicalTrials.gov registry record · Phase 3
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
A Phase 3 study of Hemophilia A, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
- 20
- Study locations
NCT02795767: Completed Phase 3 study of Hemophilia A, sponsored by Hoffmann-La Roche.
NCT02795767 is a Phase 3 study of Hemophilia A that has completed, run by Hoffmann-La Roche. The registered enrollment target is 88 participants, roughly in line with the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02795767, a Phase 3 study of Hemophilia A, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
- 20
- Study locations
Study Summary
This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.
Primary Outcome
The number of treated bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times. A bleed is considered a "treated bleed" if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a "treatment for bleed", irrespective of time between treatment and the preceding bleed. A bleed and the first treatment the
Conditions Studied
Interventions
- DRUG Emicizumab
Study Locations (20)
Other
- ICIC - San José
- Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique - Bron
- CH de Bicetre; Centre de Traitement d' Hemophilie - Le Kremlin-Bicêtre
- Groupe Hospitalier Necker Enfants Malades - Paris
- Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin - Bonn
- Nagoya University Hospital - Aichi
- Hospital of the University of Occupational and Environmental Health,Japan - Kitakyushu-shi
- Nara Medical University Hospital - Nara
- Shizuoka Children's Hospital - Shizuoka
- Ogikubo Hospital - Tokyo
- Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center - Johannesburg
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- University of Colorado Denver, Children's Hospital - Aurora
Georgia
- Children'S Healthcare of Atlanta - Atlanta
Illinois
- Rush Medical Center - Chicago
Michigan
- Children's Hospital of Michigan; Pediatrics - Detroit
New York
- North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation - New Hyde Park
Oregon
- Oregon Health & Science Uni ; Dept of Pediatrics - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2020-11-11 |
| Phase | Phase 3 |
What the finished NCT02795767 record still lists
NCT02795767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, roughly in line with the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Emicizumab is the first listed.
NCT02795767 names 20 study sites across 10 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02795767 about?
NCT02795767 is a clinical study titled "A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors". This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional ...
What is the current status of trial NCT02795767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2016-07-22. Estimated completion is 2020-11-11.
What conditions does trial NCT02795767 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT02795767?
The interventions under investigation include: Emicizumab (DRUG).
Who is sponsoring clinical trial NCT02795767?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02795767 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
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 NCT02795767's enrollment target sits among peer trials
88 14th of 42 higher than 29 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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