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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: Completed Phase 4 study of Hemophilia A, sponsored by Swedish Orphan Biovitrum.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients who achieve ITI success where ITI success is defined as achieving all 3 of the following criteria: * Negative titer for inhibitor (\<0.6 Bethesda units/mL by the Nijmegen-modified Bethesda assay) at 2 consecutive visits * FVIII incremental recovery (IR) \>66% of the expected IR at 2 consecutive visits * FVIII half-life (t½) ≥7 hours
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-08-29 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 4 |
What the finished NCT03103542 record still lists
NCT03103542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (82% lower).
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 lists 12 locations in 2 states (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.
Learn More About Clinical Trials
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Where NCT03103542's enrollment target sits among peer trials
16 33rd of 42 higher than 10 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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