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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Octapharma

ClinicalTrials.gov Identifier:

NCT00989196

First received: September 30, 2009

Last updated: October 2, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 30, 2009

Last Updated Date

October 2, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the curve [ Time Frame: Within the first few weeks after screening ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00989196 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Biological: recombinant FVIII
50 IU/kg for PK dose
Biological: Kogenate FS
50 IU/kg for PK dose

Study Arm (s)

Experimental: recombinant FVIII
Intervention: Biological: recombinant FVIII
Active Comparator: Kogenate FS
Intervention: Biological: Kogenate FS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Severe hemophilia A (FVIII:C <= 1%)
Male subjects between 12 and 65 years of age
Body weight 25 kg to 110 kg
Previously treated with FVIII concentrate for at least 150 EDs

Exclusion Criteria:

Other coagulation disorder than hemophilia A
Present or past FVIII inhibitor activity

Gender

Male

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Bulgaria, Germany

Administrative Information

NCT Number ^ICMJE

NCT00989196

Other Study ID Numbers ^ICMJE

GENA-01

Has Data Monitoring Committee

Yes

Responsible Party

Octapharma

Study Sponsor ^ICMJE

Octapharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Sigurd Knaub, PhD

Octapharma

Information Provided By

Octapharma

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top