NCT01205724|CompletedPhase 1

Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

pathfinder™1

A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7088-37762010-018520-68U1111-1116-2043JapicCTI-101293

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredSep 2010

StartedSep 2010

CompletionApr 2011

Brief Summary

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Sep 2010

Shorter than P25 for phase_1

Geographic Reach

7 countries

18 active sites

Status

completed

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

7 months study duration

Study Start

First participant enrolled

September 1, 2010

Completed

16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed

Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

September 17, 2010

Last Update Submit

February 9, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Frequency of adverse events (AEs) reported after administration of trial product
up to four weeks after trial product administration

Secondary Outcomes (2)

Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample)
from 0 to 168 hours after trial product administration
Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments
up to four weeks after trial product administration

Study Arms (3)

A

EXPERIMENTAL

Drug: turoctocog alfa pegol

B

EXPERIMENTAL

Drug: turoctocog alfa pegol

C

EXPERIMENTAL

Drug: turoctocog alfa pegol

Interventions

turoctocog alfa pegolDRUG

Single dose (low) administered intravenously (into the vein)

Also known as: NNC 0129-0000-1003

Eligibility Criteria

Age18 Years - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Haemophilia A
Body Mass Index (BMI) below 35 kg/m2
History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)

You may not qualify if:

Any history of FVIII inhibitors
Surgery planned to occur during the trial
Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
Congenital or acquired coagulation disorders other than haemophilia A

Contact the study team to confirm eligibility.