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Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184820
First Posted: August 19, 2010
Last Update Posted: November 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose

The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test drug). Pharmacokinetics means that we will measure how well the study drug corrects the factor VIII levels in your blood and how long it takes for the levels to fall back to your baseline level. The study is also designed to determine if the pharmacokinetics of BAY94-9027 change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe, tolerable, and effective for the treatment of severe hemophilia A and define the appropriate dose of BAY94-9027. Two doses of BAY94-9027 will be studied.

The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort 2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses). All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see describe the PK. Safety & tolerability assessment include vital signs, coagulation and hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene glycol (PEG) antibodies will be done during the course of the study.


Condition Intervention Phase
Hemophilia A Biological: BAY94-9027 + Kogenate FS (Recombinant Factor VIII, BAY14-2222) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label Phase 1 Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration in Two Cohorts of Previously Treated Male Subjects With Severe Hemophilia A

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety as assessed by measuring antibody to FVIII [ Time Frame: 2 months ]
  • Adverse event collection [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters will be measured by Tmax, Cmax, t1/2, AUC, and incremental recovery. [ Time Frame: 2 months ]

Enrollment: 14
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: BAY94-9027 + Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Single dose of Kogenate FS and 16 doses of BAY94-9027 given 2 times a week for 8 weeks. Both drugs to be given intravenously.
Experimental: Arm 2 Biological: BAY94-9027 + Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Single dose of Kogenate FS and 9 doses of BAY94-9027 given once a week for 8 weeks. Both drugs to be given intravenously.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects with severe hemophilia A (documented plasma baseline Factor VIII level <1 %)
  • >/= 18 but </= 65 years of age
  • Previously treated with Factor VIII concentrate(s) for a minimum of 150 exposure days (as supported by the subject's medical history)
  • Immunocompetent with a CD4+ lymphocyte count > 400/mm³
  • Signed informed consent from subject

Exclusion Criteria:

  • Documented history of inhibitor to Factor VIII with a titer >/= 0.6 BU (Biological Unit), by the Nijmegen modified assay. However, subjects with a maximum historical titer of </= 1.0 BU with the classical Bethesda assay on a single measurement but with at least 3 subsequent successive negative results (< 0.6 BU) thereafter are eligible.
  • Unable to stop Factor VIII treatment to complete a minimum 72 hour washout
  • Current evidence of inhibitor to Factor VIII with a titer >/= 0.6 BU, measured at the time of screening
  • Abnormal renal function (serum creatinine > 1.5 times the upper limit of the normal range)
  • Total bilirubin > 1.5 times the upper limit of the normal range
  • Active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels > 2 times the upper limit of the normal range)
  • Any concomitant coagulation disorder other than hemophilia A (including lupus anticoagulant)
  • Platelet count < 100,000/mm³
  • Within the last 3 months prior to study entry or during the study will be treated with an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a interferon, steroids, rituximab, etc)
  • Any subject who requires major surgery during study period. Minor procedures may be approved if discussed in advance with the medical expert.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184820


Locations
United States, California
Davis, California, United States, 95616
United States, Louisiana
New Orleans, Louisiana, United States, 70112-2699
United States, Massachusetts
Boston, Massachusetts, United States, 02115-6195
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01184820     History of Changes
Other Study ID Numbers: 13401
First Submitted: July 13, 2010
First Posted: August 19, 2010
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Pharmacokinetics
Safety

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants