BAY94-9027 PK Study Comparing to Anothe… | Clinical Trial

Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Sofia, 1756, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Damoctocog (Jivi, BAY94-9027)

Drug

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

ELOCTA

Drug

60 IU/kg, given as a 10 minute injection, 1 dose

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Dec 7, 2017
Registry last updated: Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed