Overview

This trial is active, not recruiting.

Conditions congenital bleeding disorder, haemophilia a
Treatments turoctocog alfa pegol
Phase phase 3
Sponsor Novo Nordisk A/S
Start date January 2012
End date December 2018
Trial size 186 participants
Trial identifier NCT01480180, 2011-001142-15, JapicCTI-121749, NN7088-3859, U1111-1119-7416

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
turoctocog alfa pegol NNC 0129-0000-1003
Administered i.v.
(Experimental)
turoctocog alfa pegol NNC 0129-0000-1003
Administered i.v.

Primary Outcomes

Measure
The Incidence rate of FVIII-inhibitors greater than or equal to 0.6 BU (Bethesda Unit)
time frame: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit
Annualised bleeding rate in the prophylaxis arm
time frame: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit

Secondary Outcomes

Measure
Haemostatic effect of N8-GP when used for treatment of bleeds, assessed on a four-point scale (excellent, good, moderate and none)
time frame: The endpoints will be analysed based on all available information until the end of trial (EOT) visit and up to approximately 24 and 36 months

Eligibility Criteria

Male participants at least 12 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.