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Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

NCT00989196 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-10-08

Study results available
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Summary

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

Conditions

Interventions

BIOLOGICAL

Human-cl rhFVIII

50 IU/kg for PK dose

BIOLOGICAL

Kogenate FS

50 IU/kg for PK dose

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Sigurd Knaub, PhD · Octapharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-10-31
Completion
2012-09-30

Countries

  • United States
  • Bulgaria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT00989196 on ClinicalTrials.gov