MedTrace Logo

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

NCT02083965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-12-19

Study results available
· View outcomes & findings →

Summary

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

Conditions

  • Severe Hemophilia A

Interventions

BIOLOGICAL

rFVIIIFc

Administered as specified in the treatment arm.

Sponsors & Collaborators

  • Bioverativ Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Bioverativ Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-10-31
Completion
2015-05-31

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

More Related Trials

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 NCT02083965 on ClinicalTrials.gov