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International Immune Tolerance Study

NCT00212472 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2009-12-07

No results posted yet for this study

Summary

The purpose of this study is to see if a low-dose arm or a high dose-arm of immune tolerance is more effective in eliminating inhibitors in patients with hemophilia A.

Conditions

  • Hemophilia A With Inhibitors

Interventions

DRUG

Factor VIII concentrates

To be determined at the discretion of the investigator.

OTHER

Low-dose treatment

50 FVIII u/kg three times a week.

OTHER

High-dose treatment

200 FVIII u/kg per day.

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • New York Presbyterian Hospital

    lead OTHER

Principal Investigators

  • Donna M DiMichele, MD · Weill Cornell Medical College-NY Presybetrian Hospital

  • Charles Hay, MD · Manchester Royal Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2010-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT00212472 on ClinicalTrials.gov