Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients

NCT00914459 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-02-10

Study results available
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Summary

The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).

Conditions

Interventions

BIOLOGICAL

Moroctocog alfa ( AF-CC)

Dosing is at the discretion of the Investigator

PROCEDURE

Laboratory tests

Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • Finland
  • Georgia
  • Italy
  • Romania
  • Serbia
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT00914459 on ClinicalTrials.gov