Trials / Terminated
TerminatedNCT03588741
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213 (NCT02994407)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Turoctocog alfa | Intravenous (i.v., under the skin) administration.A maximum dose of 200 IU/kg daily. The maximum treatment period for this trial is 24 months and the patient(s) will be called for visit to the clinic every 3rd month. |
Timeline
- Start date
- 2018-06-12
- Primary completion
- 2019-06-19
- Completion
- 2019-06-19
- First posted
- 2018-07-17
- Last updated
- 2020-07-07
- Results posted
- 2020-07-07
Locations
14 sites across 7 countries: Austria, Bulgaria, France, Germany, Serbia, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03588741. Inclusion in this directory is not an endorsement.