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Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

NCT01445197 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-10-03

No results posted yet for this study

Summary

This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.

Conditions

Interventions

BIOLOGICAL

Biostate

200 IU/kg administered daily

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Carmen Escuriola-Ettingshausen · Haemophilia Centre Rhein Main, Frankfurt - Mörfelden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Austria
  • Germany
  • Greece
  • Italy
  • Russia

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 NCT01445197 on ClinicalTrials.gov