BAY94-9027 PK Study Comparing to Another Long Acting Product

Brief Title

BAY94-9027 PK Study Comparing to Another Long Acting Product

Official Title

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

Brief Summary

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

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

AUC from time 0 to the last data point

Condition

Hemophilia A

Intervention

Damoctocog (Jivi, BAY94-9027)

Study Arms / Comparison Groups

 BAY94-9027 and Elocta

Description:  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

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

November 30, 2017

Completion Date

September 28, 2018

Primary Completion Date

January 25, 2018

Eligibility Criteria

        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.

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations

NCT ID

NCT03364998

Organization ID

Secondary IDs

2017-003201-18

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

, ,

Verification Date

September 2019