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Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980

NCT00629837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-11-18

No results posted yet for this study

Summary

The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.

Conditions

Interventions

BIOLOGICAL

Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)

Low dose of BAY 79-4980 \[13mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).

BIOLOGICAL

Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)

High dose of BAY 79-4980 \[22mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU)

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 \[13mg of liposomes/kg\]

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to high dose of BAY 79-4980 \[22mg of liposomes/kg\]

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Completion
2006-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629837 on ClinicalTrials.gov