Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003821-40-GB

Enrollment

Registered

2016-12-15

Start date

2017-02-15

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A MedDRA version: 20.0 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850

Interventions

Trade Name: NovoEight Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Turoctocog alfa Other descriptive name: TUROCTOCOG ALFA Concentration unit: IU/ml internat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Previous participation in the NN7170-4213 trial (male, age = 18 years (part A) and age = 12 years (part B)). - Development of a confirmed high titre neutralising antibody towards factor VIII (>5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in the NN7170- 4213 trial or development of a confirmed clinically relevant low titre inhibitor (=0.6 to =5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleed pattern indicating a lack of clinical response to factor VIII treatment. Are the trial subjects under 18? yes Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Known or suspected hypersensitivity to trial product(s) or related products, defined as allergic reactions. - Participation in another clinical trial within 1 month before screening (except participation in NN7170-4213). - Any disorder, except for conditions associated with Haemophilia A which in the investigator’s opinion might jeopardise patients’ safety or compliance with the protocol. - Currently receiving immune tolerance induction treatment with a factor VIII containing product other than turoctocog alfa.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety of immune tolerance induction treatment with turoctocog alfa in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213;Secondary Objective: To evaluate efficacy of immune tolerance induction treatment with turoctocog alfa;Primary end point(s): Number of adverse events;Timepoint(s) of evaluation of this end point: During immune tolerance induction treatment with turoctocog alfa.	—

Measure

Time frame

Main Objective: To evaluate safety of immune tolerance induction treatment with turoctocog alfa in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213;Secondary Objective: To evaluate efficacy of immune tolerance induction treatment with turoctocog alfa;Primary end point(s): Number of adverse events;Timepoint(s) of evaluation of this end point: During immune tolerance induction treatment with turoctocog alfa.

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Secondary

Measure	Time frame
Secondary end point(s): Response to immune tolerance induction treatment (success, partial success, failure, other);Timepoint(s) of evaluation of this end point: Within a maximum immune tolerance induction treatment duration of 24 months.	—

Countries

Austria, Bulgaria, European Union, Germany, Japan, Serbia, Turkey, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026