Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

Study Description

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Brief Summary:

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.

Condition or disease	Intervention/treatment	Phase
Hemophilia A	Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; Biological: PEGylated Recombinant Factor VIII	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	159 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
Study Start Date :	January 2013
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	July 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Prophylaxis	Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; Pharmacokinetic (PK) evaluation of ADVATE; Other Name: ADVATE Biological: PEGylated Recombinant Factor VIII; Pharmacokinetic (PK) evaluation of BAX 855; Other Name: BAX 855 Biological: PEGylated Recombinant Factor VIII; Prophylaxis treatment; Other Name: BAX 855
Experimental: On-demand	Biological: PEGylated Recombinant Factor VIII; On-demand treatment; Other Name: BAX 855

Outcome Measures

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Primary Outcome Measures :

1. Annualized Bleeding Rate (ABR) [ Time Frame: 9 months ]
   Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.

Secondary Outcome Measures :

1. Rate of Success of BAX 855 for Treatment of Bleeding Episodes [ Time Frame: At least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm. ]
   Success in the control of bleeding was defined as a rating of excellent or good using the Efficacy Rating Scale for Treatment of Bleeding Episodes measured 24 hours after initiation of treatment for the bleeding episode. EXCELLENT: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. GOOD: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. FAIR: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. NONE: No improvement or condition worsens.
2. Average Number of BAX 855 Infusions Needed for the Treatment of Bleeding Episodes [ Time Frame: From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm]. ]
3. Number of Participants With ≤1, 2, 3, 4, 5, 6, or >6 Month Time Intervals Between Bleeding Episodes or no Bleeding Episodes [ Time Frame: From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm]. ]
   Interval between Bleeds in months was calculated as: Observation period for efficacy (in days)/(number of bleeds)*(12/365.2425)
4. Weight-adjusted Consumption of BAX 855 - Per Prophylactic Infusion and Pharmacokinetic (PK) Infusion [ Time Frame: Prophylactic Infusion: ≥50 exposure days or 6 months (±2 weeks), whichever occurs last. PK Infusion: PK #1 Pre-infusion within 30 minutes; Post-infusion 10 min, and 0.5, 1, 3, 6, 24, 32, 48, 56 hours (h). PK #2 also at Post-infusion 96h ]
5. Weight-adjusted Consumption of BAX 855 - Per Treatment of Bleeding Episode (BE) and Per BE for Maintenance of Hemostasis [ Time Frame: Treatment of Bleeding Episode (BE): Minor/Moderate BE every 12 to 24 hours until bleeding is resolved; Major BE every 8 to 12 hours until bleeding is resolved. Per BE for Maintenance of Hemostasis: within 48 hours after bleeding episode resolution. ]
   Infusions per bleeding episode for maintenance of hemostasis only includes infusions following the resolution of a bleed to maintain hemostasis.
6. Percentage of Participants With Adverse Events [ Time Frame: From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm]. ]
   Adverse Events (AEs) and Serious Adverse Events (SAEs)
7. Immunogenicity - Number of Participants With Positive Inhibitory Antibodies to FVIII, Binding Antibodies to FVIII, PEG-VIII, PEG and Anti-CHO Antibodies at Study Completion/Termination [ Time Frame: From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm]. ]

   Number of participants who received BAX855, with immunogenicity data from study completion/termination visit.

   FVIII = factor VIII; PEG-VIII = polyethylene glycol-factor VIII; Anti-CHO = Anti-Chinese hamster ovary

8. Patient Reported Outcomes: Haemo-SYM Questionnaire, Change in Score From Baseline to End of Study [ Time Frame: Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm]. ]

   The HAEMO-SYM has two subscales: pain and bleeds. HAEMO-SYM subscale scores are calculated by taking the mean of the items in each subscale and transforming them to a 0 (none or absent) to 100 (very severe) scale.

   Given that higher scores indicate more severe symptoms on the Haemo-SYM and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates an improvement (reduction in symptoms). Conversely, a positive change score indicates worsening symptoms.

9. Patient Reported Outcomes - Short Form (SF)-36, Change From Baseline to End of Study [ Time Frame: Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm] ]
   Change from Baseline to End of Study for SF-36 Questionnaire is provided. Scores for individual SF-36 categories range from 0 to 100 with higher scores representing better health. Given that higher scores indicate better health-related quality of life (HRQoL) and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates a worsening of HRQoL.
10. Pharmacokinetics (Pk) - Plasma Half-life (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]

    Terminal half-life calculated as log_e2/λz where λz is the terminal elimination rate constant.

    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).

11. Pharmacokinetics (Pk) - Mean Residence Time (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]

    The mean residence time (MRT) w as calculated as total area under the moment curve divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).

    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).

12. Pharmacokinetics (Pk) - Total Body Clearance (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]

    Clearance in dL/(kg.h) will be calculated as the dose in IU/kg divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).

    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).

13. Pharmacokinetics (Pk) - Incremental Recovery Over Time (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]

    Incremental recovery (IR) in (IU/dL)/ (IU/kg) calculated as: IR = (Cmax- (C pre-infusion)) / (Dose/kg), where C =concentration.

    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).

14. Pharmacokinetics (Pk) - Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC0-∞) (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]

    Calculated by WinNonlin NCA (Model 201, calculation method: Linear Trapezoidal Linear/Log Interpolation).

    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).

15. Pharmacokinetics (Pk) - Apparent Volume of Distribution at Steady State (Vss) (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]

    The apparent volume of distribution at steady state (Vss) will be calculated as: Vss = Clearance * Mean Residence Time.

    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).

16. Pharmacokinetics (Pk) - Maximum Plasma Concentration (Cmax) (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]
    Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
17. Pharmacokinetics (Pk) -Time to Maximum Concentration in Plasma (Tmax) (One-stage Clotting Assay) [ Time Frame: Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only). ]
    Tmax in hours will be defined as the time to reach Cmax. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
18. Change in Vital Signs From Screening - Temperature [ Time Frame: Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination ]
19. Change in Vital Signs From Screening - Pulse Rate [ Time Frame: Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination ]
20. Change in Vital Signs From Screening - Respiratory Rate [ Time Frame: Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination ]
21. Changes in Vital Signs From Screening - Blood Pressure [ Time Frame: Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination ]
    Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)
22. Changes in Clinical Chemistry Laboratory Assessments From Screening - Albumin and Protein [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
23. Changes in Clinical Chemistry Laboratory Assessments From Screening - Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
    Alkaline Phosphatase (Alk Phos); Alanine Aminotransferase (Ala Amino); Aspartate Aminotransferase (Asp Amino)
24. Changes in Clinical Chemistry Laboratory Assessments From Screening - Bicarbonate, Chloride, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
25. Changes in Clinical Chemistry Laboratory Assessments From Screening - Creatinine, and Bilirubin [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
26. Changes in Hematology Laboratory Assessments From Screening - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
27. Changes in Hematology Laboratory Assessments From Screening - Hematocrit [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
28. Changes in Hematology Laboratory Assessments From Screening - Hemoglobin [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
29. Changes in Hematology Laboratory Assessments From Screening - Erythrocytes [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]
30. Changes in Lipid Panel Assessments From Screening - Cholesterol; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Triglycerides; and Very Low Density Lipoprotein (VLDL) [ Time Frame: Screening, week 2, week 4, month 3, study completion/termination ]

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

• Participant and/or legal representative has/have voluntarily provided signed informed consent
• Participant is 12 to 65 years old at the time of screening
• Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity < 1%) as confirmed by central laboratory at screening after the appropriate washout period or a documented FVIII clotting activity <1%
• Participant has been previously treated with plasma-derived FVIII concentrates or recombinant FVIII for ≥150 documented exposure days (EDs)
• Participant is currently receiving prophylaxis or on-demand therapy with FVIII
• Participant is willing and able to comply with the requirements of the protocol

Main Exclusion Criteria:

• Participant has detectable FVIII inhibitory antibodies (≥ 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening
• Participant has history of FVIII inhibitory antibodies (≥ 0.4 BU using the Nijmegen modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time prior to screening
• Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).

Contacts and Locations

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Locations

United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida, College of Medicine
Gainesville, Florida, United States, 32610
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61614
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40504
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Medical School
New Orleans, Louisiana, United States, 70124
United States, Missouri
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States, 66211
United States, New York
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Palmetto Health
Columbia, South Carolina, United States, 29203
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Washington
Puget Sound Blood Group
Seattle, Washington, United States, 98104
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Hollywood Specialist Centre
Nedlands, Western Australia, Australia, 6009
Austria
Landes-Frauen-und Kinderklinik Linz
Linz, Austria, 4020
AKH - Medizinische Universität Wien
Vienna, Austria, 1090
Bulgaria
SHAT of Oncohaematology Diseases
Sofia, Bulgaria, 1527
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 61300
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
Fakultni nemocnice v Motole
Praha 5, Czechia, 150 06
Germany
Gerinnungszentrum Rhein-Ruhr
Duisburg, Nordrhein Westfalen, Germany, 47051
Vivantes Klinikum im Friedrichshain - Landsberger Allee
Berlin, Germany, 10249
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Werlhof-Institut MVZ
Hannover, Germany, 30159
Israel
Rambam Health Care Campus
Haifa, Israel, 3109601
Chaim Sheba Medical Center
Tel Aviv, Israel, 64239
Japan
Nagoya University Hospital
Nagoya-shi, Aichi-Ken, Japan, 466-8560
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka-Ken, Japan, 807-8556
Hiroshima University Hospital
Hiroshima-shi, Hiroshima-Ken, Japan, 734-8551
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyogo-Ken, Japan, 663-8501
St. Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa-Ken, Japan, 216-8511
Nara Medical University Hospital
Kashihara-shi, Nara-Ken, Japan, 634-8522
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo-To, Japan, 160-0023
Ogikubo Hospital
Suginami-ku, Tokyo-To, Japan, 167-8515
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Eulji University Hospital
Daejeon, Korea, Republic of, 302-120
Kyung hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Lithuania
Vilnius University Hospital Santariskiu Clinics, Public Institution
Vilnius, Lithuania, 08661
Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, LT-08406
Malaysia
Penang General Hospital
Penang, Pulau Pinang, Malaysia, 10990
Hospital Tengku Ampuan Rahimah
Klang, Selangor, Malaysia, 41200
Pusat Darah Negara
Kuala Lumpur, Malaysia, 50400
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Wojewodzki Szpital Specjalistyczny im.M.Kopernika w Lodzi
Lodz, Poland, 93-510
Romania
Sanador SRL
Bucuresti, Romania, 011026
Spain
Hospital Universitari Son Espases
Palma de Mallorca, Baleares, Spain, 07010
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Hospital Regional Universitario de Malaga
Malaga, Málaga, Spain, 29010
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Sweden
Skånes Universitetssjukhus, Malmö
Malmö, Sweden, 20502
Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden, 17176
Switzerland
Universitatsspital Zurich
Zurich, Switzerland, 8091
Taiwan
Tri-Service General Hospital
Taipei, Taiwan, 11490
Ukraine
SI V.K.Gusak Emergency and Reconstructive Surgery Institute of NAMSU Center of IT
Donetsk, Ukraine, 83045
SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
Lviv, Ukraine, 79044
United Kingdom
Bristol Royal Hospital for Children
Bristol, Avon, United Kingdom, BS2 8BJ
Royal Free Hospital
London, Greater London, United Kingdom, NW3 2QG
St Thomas' Hospital
London, Greater London, United Kingdom, SE1 7EH
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom, M13 9WL
Royal Manchester Children's Hospital
Manchester, Greater Manchester, United Kingdom, M13 9WL
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ

Sponsors and Collaborators

Baxalta now part of Shire

Investigators

Study Director:	Brigitt Abbuehl, MD	Baxter Innovations GmbH

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Konkle BA, Stasyshyn O, Chowdary P, Bevan DH, Mant T, Shima M, Engl W, Dyck-Jones J, Fuerlinger M, Patrone L, Ewenstein B, Abbuehl B. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015 Aug 27;126(9):1078-85. doi: 10.1182/blood-2015-03-630897. Epub 2015 Jul 8.

Responsible Party:	Baxalta now part of Shire
ClinicalTrials.gov Identifier:	NCT01736475 History of Changes
Other Study ID Numbers:	261201; 2012-003599-38 ( EudraCT Number )
First Posted:	November 29, 2012
Results First Posted:	September 7, 2016
Last Update Posted:	November 24, 2017
Last Verified:	July 2016

Additional relevant MeSH terms:

Hemophilia A; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Coagulation Protein Disorders	Hemorrhagic Disorders; Genetic Diseases, Inborn; Factor VIII; Coagulants