BAY94-9027 PK Study Comparing to Another Long Acting Product

NCT03364998 | Completed Phase 1 FDA Drug

• 2 other identifiers: 190962017-003201-18
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (1)

• AUC from time 0 to the last data point

  Area under the concentration time profile curve.

  Pre-Dose and up to 120 hours post dose

Study Arms (2)

BAY94-9027 and Elocta

EXPERIMENTAL

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); Drug: Elocta

Elocta and BAY94-9027

EXPERIMENTAL

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); Drug: Elocta

Interventions

Damoctocog (Jivi, BAY94-9027) DRUG

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

BAY94-9027 and Elocta; Elocta and BAY94-9027

Elocta DRUG

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

BAY94-9027 and Elocta; Elocta and BAY94-9027

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

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

Sofia, 1756, Bulgaria

Location

Related Publications (1)

• Shah A, Solms A, Wiegmann S, Ahsman M, Berntorp E, Tiede A, Iorio A, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019 Sep;98(9):2035-2044. doi: 10.1007/s00277-019-03747-2. Epub 2019 Jun 24.

  PMID: 31236667 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 7, 2017
• Study Start: November 30, 2017
• Primary Completion: January 25, 2018
• Study Completion: September 28, 2018
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

BU (1)