Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02795767
The ClinicalTrials.gov registry entry for NCT02795767 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target. 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 Emicizumab is the first listed.
NCT02795767 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
-
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
RECRUITING · Phase 3
-
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
RECRUITING · Phase 3
-
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
RECRUITING · Phase 3
-
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
RECRUITING · Phase 3
-
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.