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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1187-7323 | Other Identifier | WHO | |
| 2016-003821-40 | EudraCT Number |
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The trial was terminated as the participant withdrew from the trial.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turoctocog alfa | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turoctocog alfa | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Vienna | 1090 | Austria | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
The trial was conducted at 1 trial site in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Turoctocog Alfa | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2018 |
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| Month 12 |
| Sofia |
| 1527 |
| Bulgaria |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Berlin | 10249 | Germany |
| Novo Nordisk Investigational Site | Duisburg | 47051 | Germany |
| Novo Nordisk Investigational Site | Homburg | 66421 | Germany |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Belgrade | 11070 | Serbia |
| Novo Nordisk Investigational Site | Niš | 18000 | Serbia |
| Novo Nordisk Investigational Site | Novi Sad | 21000 | Serbia |
| Novo Nordisk Investigational Site | Bornova-IZMIR | 35100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | London | NW3 2QG | United Kingdom |
| Novo Nordisk Investigational Site | Oxford | OX3 7LJ | United Kingdom |
| Novo Nordisk Investigational Site | Sheffield | S10 2JF | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) comprised of the participant(s) who initiated ITI treatment with turoctocog alfa.
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| ID | Title | Description |
|---|---|---|
| BG000 | Turoctocog Alfa | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety analysis set (SAS) comprised of the participant(s) who initiated ITI treatment with turoctocog alfa. | Posted | Number | Adverse events | Month 0 - up to month 12 |
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| ||||||||||||||||||||||||||
| Secondary | Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other) | 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. | FAS comprised of the participant(s) who initiated ITI treatment with turoctocog alfa. | Posted | Count of Participants | Participants | Month 12 |
|
Month 0 - up to month 12
Results are based on the safety analysis set (SAS), which comprised the participant(s) who initiated ITI treatment with turoctocog alfa.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Turoctocog Alfa | 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. | 0 | 1 | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 22.0 | Systematic Assessment |
| |
| Muscle disorder | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 22.0 | Systematic Assessment |
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The trial was terminated as the participant withdrew from the trial.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Jun 12, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
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| >=65 years |
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