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Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

NCT ID: NCT03588741

Last Updated: 2020-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2019-06-19

Brief Summary

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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)

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Detailed Description

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Conditions

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Haemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Turoctocog alfa

Group Type EXPERIMENTAL

Turoctocog alfa

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previous participation in the NN7170-4213 trial (male, age at least 18 years (part A) and age at least 12 years (part B))
* Development of a confirmed high titre neutralising antibody towards factor VIII (greater than 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 (at least 0.6 to below or equal to 5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleedpattern indicating a lack of clinical response to factor VIII treatment

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
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Nantes, , France

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Duisburg, , Germany

Site Status

Novo Nordisk Investigational Site

Homburg, , Germany

Site Status

Novo Nordisk Investigational Site

Belgrade, , Serbia

Site Status

Novo Nordisk Investigational Site

Belgrade, , Serbia

Site Status

Novo Nordisk Investigational Site

Niš, , Serbia

Site Status

Novo Nordisk Investigational Site

Novi Sad, , Serbia

Site Status

Novo Nordisk Investigational Site

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Oxford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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Austria Bulgaria France Germany Serbia Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1187-7323

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003821-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN7170-4345

Identifier Type: -

Identifier Source: org_study_id

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