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Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive

NCT01051544 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-12-17

No results posted yet for this study

Summary

This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for success.

Conditions

  • Severe Hemophilia A

Interventions

DRUG

FVIII Concentrates

Patients will be centrally randomized to receive a von Willebrand factor-free FVIII concentrate (recombinant or plasma-derived, monoclonally-purified). The choice of product brand will be based on physician / patients preferences.

DRUG

FVIII/VWF concentrates

Patients will be centrally randomized to receive a FVIII/VWF concentrate of 200 IU/Kg by one or two bolus injections daily.The choice of product brand will be based on physician / patients preferences.

Sponsors & Collaborators

  • Charta Foundation

    collaborator OTHER

  • Grifols Biologicals, LLC

    collaborator INDUSTRY

  • CSL Behring

    collaborator INDUSTRY

  • Biotest Pharmaceuticals Corporation

    collaborator INDUSTRY

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Nadia P Ewing, MD · Clinical Professor of Pediatrics, City of Hope National Medical Center, Dept. of Pediatrics, 1500 E. Duarte Rd. Duarte, CA 91010

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-25
Primary Completion
2020-06-25
Completion
2020-06-25

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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 NCT01051544 on ClinicalTrials.gov