BAY94-9027 PK Study Comparing to Another Long Acting Product

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03364998

Collaborator

(none)

Enrollment

Location

Arms

9.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia A	Drug: Damoctocog (Jivi, BAY94-9027) Drug: Elocta	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta

Actual Study Start Date :

Nov 30, 2017

Actual Primary Completion Date :

Jan 25, 2018

Actual Study Completion Date :

Sep 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAY94-9027 and Elocta Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment	Drug: Damoctocog (Jivi, BAY94-9027) 60 international units (IU)/kg, given as a 10 minute injection, 1 dose Drug: Elocta 60 IU/kg, given as a 10 minute injection, 1 dose
Experimental: Elocta and BAY94-9027 Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment	Drug: Damoctocog (Jivi, BAY94-9027) 60 international units (IU)/kg, given as a 10 minute injection, 1 dose Drug: Elocta 60 IU/kg, given as a 10 minute injection, 1 dose

Arm

Intervention/Treatment

Experimental: BAY94-9027 and Elocta

Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment

Drug: Damoctocog (Jivi, BAY94-9027)

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

Drug: Elocta

60 IU/kg, given as a 10 minute injection, 1 dose

Experimental: Elocta and BAY94-9027

Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment

Drug: Damoctocog (Jivi, BAY94-9027)

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

Drug: Elocta

60 IU/kg, given as a 10 minute injection, 1 dose

Outcome Measures

Primary Outcome Measures

AUC from time 0 to the last data point [Pre-Dose and up to 120 hours post dose]
Area under the concentration time profile curve.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Males, age 18 to 65 years.
Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
≥ 150 exposure days with FVIII concentrate(s) as supported by medical records

Exclusion Criteria:

Evidence of current or past inhibitor antibody:
History of any congenital or acquired coagulation disorders other than hemophilia A.
Platelet count <75,000/mm*3.
Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD	Sofia		Bulgaria	1756

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Click here to find results for studies related to Bayer products

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT03364998

Other Study ID Numbers:

19096
2017-003201-18

First Posted:

Dec 7, 2017

Last Update Posted:

Sep 9, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Hemophilia A

Factor VIII

Study Results

No Results Posted as of Sep 9, 2019