NCT03588741|TerminatedPhase 3ResultsFDA Drug

Study Stopped

The trial was terminated as the participant withdrew from the trial.

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN7170-4345U1111-1187-73232016-003821-40

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredJul 2018

StartedJun 2018

CompletionJun 2019

Brief 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)

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jun 2018

Shorter than P25 for phase_3

Geographic Reach

7 countries

14 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

June 12, 2018

Completed

Same day until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed

Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

June 12, 2018

Results QC Date

June 12, 2020

Last Update Submit

July 2, 2020

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

Number of Adverse Events
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.
Month 0 - up to month 12

Secondary Outcomes (1)

Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other)
Month 12

Study Arms (1)

Turoctocog alfa

EXPERIMENTAL

Drug: Turoctocog alfa

Interventions

Turoctocog alfaDRUG

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.

Turoctocog alfa

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.