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Study Evaluating Betrixaban in Pediatric Participants

NCT03346083 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-01-12

Study results available
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Summary

This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).

Conditions

  • VTE Prophylaxis

Interventions

DRUG

Betrixaban

Factor Xa inhibitor.

Sponsors & Collaborators

  • Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2019-10-08
Completion
2019-10-08
FDA Drug
Yes

Countries

  • United States
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03346083 on ClinicalTrials.gov