A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A (PROTECT-VIII)

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01580293
First received: March 28, 2012
Last updated: April 8, 2014
Last verified: April 2014

March 28, 2012
April 8, 2014
April 2012
June 2014   (final data collection date for primary outcome measure)
Annualized number of total bleeds [ Time Frame: In the period of 36 weeks after Baseline ] [ Designated as safety issue: No ]
Annualized number of total bleeds [ Time Frame: In the period of 32 weeks after Baseline ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01580293 on ClinicalTrials.gov Archive Site
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: Baseline visit up until end of treatment ] [ Designated as safety issue: Yes ]
  • Quantification of blood loss in major surgery [ Time Frame: Pre-surgery infusion up to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters will be measured by Tmax, Cmax, t1/2, AUC, and incremental recovery [ Time Frame: Baseline, 36 weeks ] [ Designated as safety issue: No ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: Baseline visit up to 32 weeks ] [ Designated as safety issue: Yes ]
  • Quantification of blood loss in major surgery [ Time Frame: Pre-surgery infusion up to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters will be measured by Tmax, Cmax, t1/2, AUC, and incremental recovery [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability.

The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.

In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A.

120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary.

Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.

Subjects in prophylactic treatment arms will undergo clinical evaluation at 10 weeks. Those with adequate control of bleeding will undergo randomization to every 5 or 7 day infusion. Those with continued bleeding will remain in treatment arm and have an increase in dose.

Part B-major surgery - optional sub study included to collect information on efficacy of BAY94-9027 in major surgical setting. Due to rarity of surgery in this population, enrollment to this sub-study may be independent of participation in main study.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemophilia A
Biological: BAY94-9027
Intravenous infusion of BAY94-9027
  • Experimental: Arm 1
    On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds
    Intervention: Biological: BAY94-9027
  • Experimental: Arm 2
    Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by 2 infusions per week over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED
    Intervention: Biological: BAY94-9027
  • Experimental: Arm 3
    Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by infusion every 5 days over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED
    Intervention: Biological: BAY94-9027
  • Experimental: Arm 4
    Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by infusion every 7 days over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED
    Intervention: Biological: BAY94-9027
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male; 12-65 years of age
  • Subjects with severe hemophilia A
  • Previously treated with factor VIII for a minimum of 150 exposure days

Exclusion Criteria:

  • Inhibitors to FVIII (current evidence or history)
  • Any other inherited or acquired bleeding disorder in addition to Hemophilia A
  • Platelet count < 100,000/mm3
  • Creatinine > 2x upper limit of normal or AST/ALT (aspartate aminotransferase/alanine aminotransferase) > 5x upper limit of normal
Male
12 Years to 65 Years
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
United States,   Argentina,   Austria,   Belgium,   Canada,   Colombia,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Romania,   Singapore,   Sweden,   Taiwan,   Turkey,   United Kingdom
 
NCT01580293
13024, 2011-005210-11
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

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