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COMPLETED Phase 3

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

NCT02795767 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 88 participants
Start Date 2016-07-22
Est. Completion 2020-11-11
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02795767 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02795767?

The interventions under investigation include: Emicizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02795767?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial