Study Completed

Hemophilia A

Bayer Identifier:

19096

ClinicalTrials.gov Identifier:

NCT03364998

EudraCT Number:

2017-003201-18

EU CT Number:

Not Available

BAY94-9027 PK study comparing to another long acting product

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

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.

Trial summary

Enrollment Goal

Trial Dates

November 2017 - September 2018

Phase

Phase 1

Could I Receive a placebo

Products

Jivi (Damoctocog, BAY94-9027)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD	Sofia, 1756, Bulgaria

Primary Outcome

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

Trial design

Single dose, open label, randomized, crossover study in subjects with severe hemophilia A comparing pharmacokinetic parameters of BAY 94 9027 and Elocta

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

N/A

Assignment

Crossover Assignment

Trial Arms

Additional Information

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