Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

Brief Title

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

Official Title

A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

Brief Summary

      This trial is conducted globally. The aim of the trial is to evaluate the safety and
      efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC
      0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months

Secondary Outcome

 Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months

Condition

Congenital Bleeding Disorder

Intervention

turoctocog alfa pegol

Study Arms / Comparison Groups

 Prophylaxis

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

January 30, 2012

Completion Date

December 10, 2018

Primary Completion Date

December 10, 2018

Eligibility Criteria

        Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity
        below 1%, according to medical records) - Documented history of at least 150 EDs (exposure
        days) to other FVIII products - At least 12 years and body weight at least 35 kg (except
        for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be
        18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal
        after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or
        equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by
        medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral
        load of more than 400000 copies/mL. If the data is not available in medical records within
        last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired
        coagulation disorders other than haemophilia A - Previous significant thromboembolic events
        (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined
        by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value
        at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of
        normal reference ranges at central laboratory - Creatinine level equal to or greater than
        1.5 times above upper normal limit (according to central laboratory reference ranges) -
        Ongoing immune modulating or chemotherapeutic medication

Gender

Male

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Global Clinical Registry (GCR, 1452), ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT01480180

Organization ID

NN7088-3859

Secondary IDs

U1111-1119-7416

Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S

Study Sponsor

Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Verification Date

April 2020