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A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)

NCT03205163 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-04-19

Study results available
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Summary

The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.

Conditions

Interventions

BIOLOGICAL

Advate (Low Dose)

Participants received a single IV low dose of Advate 25 IU/kg.

BIOLOGICAL

Advate (High Dose)

Participants received a single IV high dose of Advate 65 IU/kg.

BIOLOGICAL

BIVV001 (Low Dose)

Participants received single IV low dose of BIVV001 25 IU/kg.

BIOLOGICAL

BIVV001 (High Dose)

Participants received single IV high dose of BIVV001 65 IU/kg.

Sponsors & Collaborators

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2018-11-12
Completion
2018-11-12
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Diseases

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 NCT03205163 on ClinicalTrials.gov