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NCT03103542 · ClinicalTrials.gov registry record · Phase 4

Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies

A Phase 4 study of Hemophilia A, sponsored by Swedish Orphan Biovitrum.

Completed
Registry status
Phase 4
Development phase
16
Enrollment target
12
Study locations

NCT03103542 is a Phase 4 study of Hemophilia A that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 16 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (82% lower). The trial reports 12 study locations across 2 states.

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The verdict

NCT03103542, a Phase 4 study of Hemophilia A, has completed, sponsored by Swedish Orphan Biovitrum.

COMPLETED
Registry status
Phase 4
Development phase
16 participants
Enrollment target
12
Study locations

Study Summary

The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at tolerization.

Conditions Studied

Hemophilia A

Interventions

  • BIOLOGICAL Recombinant coagulation factor (rFVIIIFc)

Study Locations (12)

Other

  • Swedish Orphan Biovitrum Research Site - Hamilton
  • Swedish Orphan Biovitrum Research Site - Vancouver
  • Swedish Orphan Biovitrum Research Site - Bonn
  • Swedish Orphan Biovitrum Research Site - Frankfurt am Main
  • Swedish Orphan Biovitrum Research Site - Mörfelden-Walldorf
  • Swedish Orphan Biovitrum Research site - Dublin
  • Swedish Orphan Biovitrum Research Site - Ljubljana
  • Swedish Orphan Biovitrum Research site - Gothenburg
  • Swedish Orphan Biovitrum Research Site - Birmingham
  • Swedish Orphan Biovitrum Research Site - Liverpool
  • Swedish Orphan Biovitrum Research Site - London

District of Columbia

  • Swedish Orphan Biovitrum Research Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2017-08-29
Est. Completion 2020-08-31
Phase Phase 4

Sponsor

Swedish Orphan Biovitrum

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03103542

The ClinicalTrials.gov registry entry for NCT03103542 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (82% lower). The listed sponsor is Swedish Orphan Biovitrum, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Recombinant coagulation factor (rFVIIIFc) is the first listed.

NCT03103542 reports 12 study locations spanning 2 distinct geographic areas - top geographies include Other, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03103542 about?

NCT03103542 is a clinical study titled "Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies". The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at tolerization.

What is the current status of trial NCT03103542?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2017-08-29. Estimated completion is 2020-08-31.

What conditions does trial NCT03103542 study?

This clinical trial studies the following conditions: Hemophilia A.

What interventions are being tested in trial NCT03103542?

The interventions under investigation include: Recombinant coagulation factor (rFVIIIFc) (BIOLOGICAL).

Who is sponsoring clinical trial NCT03103542?

This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03103542 being conducted?

This trial has 12 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.