Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

NCT02941354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-01-30

No results posted yet for this study

Summary

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A

Interventions

DRUG

turoctocog alfa

Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2017-06-20
Completion
2017-06-20
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Germany
  • Serbia
  • Spain
  • Taiwan

Study Locations

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Entities

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 NCT02941354 on ClinicalTrials.gov