A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A (Leopold II)

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01233258

First received: November 2, 2010

Last updated: January 25, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2010

Last Updated Date

January 25, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Annualized number of all bleeds [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01233258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Annualized number of all bleeds with 2 potency assignments [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Response to treatment of bleeds as measured by proportion of bleeds treated with 1 or 2 infusions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Bleeding rates by dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Response to treatment of bleeds as measured by questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

Official Title ^ICMJE

A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With BAY81-8973 (rFVIII Formulated With Sucrose)

Brief Summary

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Biological: Recombinant Factor VIII (BAY81-8973)
On-demand treatment with BAY81-8973 assayed by CS/EP (Chromogenic substrate/European Pharmacopoeia assay) for 6 months, followed by cross-over to BAY81-8973 assayed by CS/ADJ (Chromogenic substrate/one-stage adjusted assay) for 6 months.
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with high-dose BAY81-8973 assayed by CS/EP for 6 months, followed by cross-over to BAY81-8973 assayed by CS/ADJ for 6 months.
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with low-dose BAY81-8973 assayed by CS/EP for 6 months, followed by cross-over to BAY81-8973 assayed by CS/ADJ for 6 months.
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with high-dose BAY81-8973 assayed by CS/ADJ for 6 months, followed by cross-over to BAY81-8973 assayed by CS/EP for 6 months.
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with low-dose BAY81-8973 assayed by CS/ADJ for 6 months, followed by cross-over to BAY81-8973 assayed by CS/EP for 6 months.
Biological: Recombinant Factor VIII (BAY81-8973)
On-demand treatment with BAY81-8973 assayed by CS/ADJ for 6 months, followed by cross-over to BAY81-8973 assayed by CS/EP for 6 months .

Study Arm (s)

Experimental: Arm 1
Intervention: Biological: Recombinant Factor VIII (BAY81-8973)
Experimental: Arm 2
Intervention: Biological: Recombinant Factor VIII (BAY81-8973)
Experimental: Arm 3
Intervention: Biological: Recombinant Factor VIII (BAY81-8973)
Experimental: Arm 4
Intervention: Biological: Recombinant Factor VIII (BAY81-8973)
Experimental: Arm 5
Intervention: Biological: Recombinant Factor VIII (BAY81-8973)
Experimental: Arm 6
Intervention: Biological: Recombinant Factor VIII (BAY81-8973)

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

December 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male, aged 12 to 65 years
Severe hemophilia A
History of more than 150 exposure days (ED) with clotting factor concentrates
Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
No current Factor VIII inhibitor or history of inhibitor
Willing to use electronic patient diary

Exclusion Criteria:

Presence of another bleeding disease that is different from hemophilia A
Thrombocytopenia
Abnormal renal function
Presence of active liver disease
Known hypersensitivity to FVIII

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, Argentina, China, Colombia, Czech Republic, India, Indonesia, Japan, Mexico, Romania, Russian Federation, Serbia, Slovakia, South Africa, Taiwan, Thailand, Turkey, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01233258

Other Study ID Numbers ^ICMJE

14319, 2009-012150-20

Has Data Monitoring Committee

Yes

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

January 2013

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

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