pathfinder™7: A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02920398
• Collaborator: (none)
• Enrollment: 21
• Locations: 14
• Arms: 2
• Actual Duration (Months): 6.1
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

Condition or Disease	Intervention/Treatment	Phase
Congenital Bleeding Disorder; Haemophilia A	Drug: turoctocog alfa pegol	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.
• Actual Study Start Date: Oct 4, 2016
• Actual Primary Completion Date: Apr 7, 2017
• Actual Study Completion Date: Apr 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N8-GP pivotal	Drug: turoctocog alfa pegol; Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.
Active Comparator: N8-GP commercial	Drug: turoctocog alfa pegol; Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.

Outcome Measures

Primary Outcome Measures

1. Area under the FVIII activity-time curve [From 0 to 96 hours post injection]

Secondary Outcome Measures

1. FVIII activity 30 min post administration - dose normalised to 50 U/kg [From time of trial product administration to 96 hours post-dose]

2. Area under the FVIII activity-time curve from 0 to infinity [From time of trial product administration to 96 hours post-dose]

3. Clearance in blood plasma of FVIII activity [From time of trial product administration to 96 hours post-dose]

4. Incremental recovery in blood plasma of FVIII activity [From time of trial product administration to 96 hours post-dose]

5. Terminal half-life [From time of trial product administration to 96 hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

• Ongoing participation in pathfinder™2

• Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)

Exclusion Criteria:

• FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7

• Planned surgery during the trial

• Major surgery performed within 4 weeks prior to screening

• Previous participation in this trial. Participation is defined as signed informed consent

• Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Torrance	California	United States	90502-2004
2	Novo Nordisk Investigational Site	Iowa City	Iowa	United States	52242
3	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21287
4	Novo Nordisk Investigational Site	Dayton	Ohio	United States	45404
5	Novo Nordisk Investigational Site	Nashville	Tennessee	United States	37232
6	Novo Nordisk Investigational Site	Århus N		Denmark	8200
7	Novo Nordisk Investigational Site	Bron Cedex		France	69677
8	Novo Nordisk Investigational Site	Nantes Cedex 1		France	44093
9	Novo Nordisk Investigational Site	Berlin		Germany	10249
10	Novo Nordisk Investigational Site	Frankfurt/M.		Germany	60590
11	Novo Nordisk Investigational Site	Homburg		Germany	66421
12	Novo Nordisk Investigational Site	Groningen		Netherlands	9713 GZ
13	Novo Nordisk Investigational Site	Madrid		Spain	28046
14	Novo Nordisk Investigational Site	Málaga		Spain	29010

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02920398
• Other Study ID Numbers: NN7088-4033; 2015-005327-63; U1111-1176-9253
• First Posted: Sep 30, 2016
• Last Update Posted: Dec 15, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders

Study Results

No Results Posted as of Dec 15, 2017