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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

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ClinicalTrials.gov Identifier: NCT03588741
Recruitment Status : Terminated (The trial was terminated as the participant withdrew from the trial.)
First Posted : July 17, 2018
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Haemophilia A
Intervention Drug: Turoctocog alfa
Enrollment 1
Recruitment Details The trial was conducted at 1 trial site in Germany.
Pre-assignment Details Previously treated participants with severe haemophilia A (FVIII activity <1% according to medical records) who had developed clinically relevant FVIII inhibitors in trial NN7170-4213 were offered immune tolerance induction (ITI) treatment with turoctocog alfa.
Arm/Group Title Turoctocog Alfa
Hide Arm/Group Description The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Turoctocog Alfa
Hide Arm/Group Description The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
Full analysis set (FAS) comprised of the participant(s) who initiated ITI treatment with turoctocog alfa.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Adverse Events
Hide Description 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.
Time Frame Month 0 - up to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) comprised of the participant(s) who initiated ITI treatment with turoctocog alfa.
Arm/Group Title Turoctocog Alfa
Hide Arm/Group Description:
The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Adverse events
6
2.Secondary Outcome
Title Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other)
Hide Description ITI treatment response was categorized as: 1. Success: Undetectable inhibitor titre <0.6 bethesda units (BU) (or lower limit of quantification [LLoQ] if above 0.6 BU); Normalised FVIII in vivo recovery, defined as ≥0.013 international units (IU) per milliliter per IU per kilogram ((IU/ml)/(IU/kg)) (66% of expected incremental recovery); turoctocog alfa half-life ≥7 hours (based on FVIII activity) after 72 hours treatment-free washout period. 2. Partial success: Inhibitor titre ≤5 BU; Clinical effect of turoctocog alfa therapy as judged by the investigator. 3. Failure (one criterion had to be fulfilled): Failure to attain defined success or partial success after 24 months of ITI treatment with turoctocog alfa; Decrease in inhibitor titre after 12 months of ITI treatment <20% compared to peak titre. 4. Other: Participants not fulfilling the above criteria e.g. early withdrawal from ITI treatment, lack of adherence to recommended ITI protocol etc.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS comprised of the participant(s) who initiated ITI treatment with turoctocog alfa.
Arm/Group Title Turoctocog Alfa
Hide Arm/Group Description:
The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Success
0
   0.0%
Partial success
0
   0.0%
Failure
0
   0.0%
Other
1
 100.0%
Time Frame Month 0 - up to month 12
Adverse Event Reporting Description Results are based on the safety analysis set (SAS), which comprised the participant(s) who initiated ITI treatment with turoctocog alfa.
 
Arm/Group Title Turoctocog Alfa
Hide Arm/Group Description The participant received intravenous (i.v.) injection of 65 international units per kilogram (IU/kg) turoctocog alfa 3 times per week. The planned treatment duration was for at least 12 months and up to a maximum period of 24 months.
All-Cause Mortality
Turoctocog Alfa
Affected / at Risk (%)
Total   0/1 (0.00%)    
Hide Serious Adverse Events
Turoctocog Alfa
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Turoctocog Alfa
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Infections and infestations   
Nasopharyngitis  1  1/1 (100.00%)  3
Musculoskeletal and connective tissue disorders   
Muscle disorder  1  1/1 (100.00%)  2
Nervous system disorders   
Headache  1  1/1 (100.00%)  1
1
Term from vocabulary, 22.0
Indicates events were collected by systematic assessment
The trial was terminated as the participant withdrew from the trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03588741    
Other Study ID Numbers: NN7170-4345
U1111-1187-7323 ( Other Identifier: WHO )
2016-003821-40 ( EudraCT Number )
First Submitted: June 12, 2018
First Posted: July 17, 2018
Results First Submitted: June 12, 2020
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020