BAY94-9027 PK Study Comparing to Another Long Acting Product

September 5, 2019 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1756
        • SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC from time 0 to the last data point
Time Frame: Pre-Dose and up to 120 hours post dose
Area under the concentration time profile curve.
Pre-Dose and up to 120 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2017

Primary Completion (ACTUAL)

January 25, 2018

Study Completion (ACTUAL)

September 28, 2018

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (ACTUAL)

December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19096
  • 2017-003201-18 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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