Back to results

Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 1

Locations

Bulgaria

Study Type

Interventional

Intervention

BAY81-8973

Advate

About this trial

This is an interventional basic science trial for Hemophilia A

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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/mm3
- Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range)
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

BAY81-8973

Advate

Arm Description

BAY81-8973 infusion to analyze pharmacokinetics

Advate infusion to analyze pharmacokinetics.

Outcomes

Primary Outcome Measures

AUC(0-tlast)

Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantification

Secondary Outcome Measures

Full Information

NCT ID

NCT02483208

First Posted

June 24, 2015

Last Updated

February 15, 2016

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02483208

Brief Title

Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Official Title

Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY81-8973

Arm Type

Experimental

Arm Description

BAY81-8973 infusion to analyze pharmacokinetics

Arm Title

Advate

Arm Type

Other

Arm Description

Advate infusion to analyze pharmacokinetics.

Intervention Type

Drug

Intervention Name(s)

BAY81-8973

Intervention Description

BAY81-8973 infusion to analyze pharmacokinetics

Intervention Type

Drug

Intervention Name(s)

Advate

Intervention Description

Advate infusion to analyze pharmacokinetics.

Primary Outcome Measure Information:

Title

AUC(0-tlast)

Description

Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantification

Time Frame

Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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/mm3 Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range) Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

12. IPD Sharing Statement

Citations:

PubMed Identifier

28005225

Citation

Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.

Results Reference

derived

Learn more about this trial

Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

We'll reach out to this number within 24 hrs