Trials / Completed
CompletedNCT03103542
Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies
A Non-Controlled, Open-Label, Multicenter, Study of Immune Tolerance Induction Performed With rFVIIIFc Within a Timeframe of 60 Weeks in Severe Haemophilia A Patients With Inhibitors Who Have Failed Previous Immune Tolerance Induction Therapies
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Swedish Orphan Biovitrum · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
This is an open-label, single-arm, interventional multi-center study designed to explore ITI performed with recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) within a timeframe of 60 weeks in patients with severe haemophilia A, who have failed previous attempts at tolerization including use of immunosuppressants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant coagulation factor (rFVIIIFc) | rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement administered intravenously. |
Timeline
- Start date
- 2017-08-29
- Primary completion
- 2019-09-04
- Completion
- 2020-08-31
- First posted
- 2017-04-06
- Last updated
- 2024-09-19
- Results posted
- 2021-11-30
Locations
12 sites across 7 countries: United States, Canada, Germany, Ireland, Slovenia, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03103542. Inclusion in this directory is not an endorsement.