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NCT03204539 · ClinicalTrials.gov registry record · Phase 4

INdividualized ITI Based on Fviii(ATE) Protection by VWF

A Phase 4 study, sponsored by University of California, Davis.

Terminated
Registry status
Phase 4
Development phase
1
Enrollment target

NCT03204539 is a Phase 4 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 1 participants.

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The verdict

NCT03204539, a Phase 4 study, was terminated before completion, sponsored by University of California, Davis.

TERMINATED
Registry status
Phase 4
Development phase
1 participants
Enrollment target

Study Summary

The primary goal of the INITIATE trial is to compare the clinical outcome of individualized lot selection to random lot selection utilizing one plasma-derived von Willebrand factor (VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in subjects with congenital Hemophilia A, FVIII activity ≤2%, and a historical high-titer inhibitor \[≥5 Bethesda Unit (BU)\].

Interventions

  • DRUG Wilate

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2017-06-01
Est. Completion 2019-07-19
Phase Phase 4

Sponsor

University of California, Davis

657 total trials

What the Registry Record Tells You About NCT03204539

The ClinicalTrials.gov registry entry for NCT03204539 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Wilate is the first listed.

NCT03204539 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03204539 about?

NCT03204539 is a clinical study titled "INdividualized ITI Based on Fviii(ATE) Protection by VWF". The primary goal of the INITIATE trial is to compare the clinical outcome of individualized lot selection to random lot selection utilizing one plasma-derived von Willebrand factor (VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in subjects with congenital H...

What is the current status of trial NCT03204539?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2017-06-01. Estimated completion is 2019-07-19.

What interventions are being tested in trial NCT03204539?

The interventions under investigation include: Wilate (DRUG).

Who is sponsoring clinical trial NCT03204539?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.