Back to resultsAn Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
Primary Purpose
Hemophilia A
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rVIII-SingleChain
Octocog alfa
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia A
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records.
- Males between 18 and 65 years of age (Parts 1 and 2).
- Males between 12 and 65 years of age (Part 3).
- Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product
- Written informed consent for study participation obtained before undergoing any study specific procedures.
Exclusion Criteria:
- Any history of or current FVIII inhibitors
- Any first order family history of FVIII inhibitors
- Use of an Investigational Medicinal Product within 30 days prior to the first rVIII-SingleChain administration.
- Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rVIII-SingleChain or reference product.
- Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
- Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
- Platelet count < 100,000/µL at screening.
- Human immunodeficiency virus (HIV) positive subjects with a CD4 count < 200/mm3, in their medical history or at screening if available results are older than one year. (HIV positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the Investigator).
- Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
- Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening.
- Subjects with serum creatinine values > 2 x ULN at Screening.
- Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1.
- Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Day 1.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recombinant Factor VIII (rFVIII)
Arm Description
Outcomes
Primary Outcome Measures
Treatment Success
The investigator rated the efficacy of the treatment based on a 4-point rating scale "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation.
Inhibitor Formation to FVIII
Number of subjects who develop inhibitors to FVIII
Annualized Spontaneous Bleeding Rate
The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest).
Treatment Success During the Peri-operative Surgical Sub-study
Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator.
Secondary Outcome Measures
AUC0-∞ (Part 1)
AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Cmax (Part 1)
Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Tmax (Part 1)
Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain.
Half-life (t1/2) (Part 1)
Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Mean Residence Time (MRT) (Part 1)
Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Clearance (Cl) (Part 1)
Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Volume of Distribution at Steady-state (Vss) (Part 1)
Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Incremental Recovery (Part 1)
Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds
The annualized bleeding rate was derived for each subject as follows: 365.25*(number of bleeding episodes requiring treatment) / (observed treatment period of interest).
Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis
Percentage of bleeding episodes requiring 1, 2, 3 or > 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486927
Brief Title
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
Official Title
A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
5. Study Description
Brief Summary
This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects enrolled in Parts 2 and 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recombinant Factor VIII (rFVIII)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
rVIII-SingleChain
Other Intervention Name(s)
Recombinant Factor VIII (rFVIII), CSL627
Intervention Description
In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg recombinant, single-chain coagulation factor VIII (rVIII-SingleChain) preceded by a 4-day washout period. In Parts 2 and 3 of the study, subjects received repeat injections of rVIII-SingleChain either as an on-demand or prophylaxis regimen at a dose and frequency determined by their study doctor. Subjects participating in the Part 3 PK analyses received a single infusion of 50 IU/kg rVIII-SingleChain and a repeat dose of the same strength of rVIII-SingleChain after 3 to 6 months. Subjects from Parts 2 and 3 participating in the surgical substudy received an individualized dose regimen of rVIII-SingleChain, based on the type of surgery and the clinical status of the subject.
Intervention Type
Biological
Intervention Name(s)
Octocog alfa
Other Intervention Name(s)
Human coagulation factor VIII (rDNA)
Intervention Description
In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg of octocog alfa preceded by a 4-day washout period. Octocog alfa is the international nonproprietary name (INN) for recombinant human coagulation factor VIII.
Primary Outcome Measure Information:
Title
Treatment Success
Description
The investigator rated the efficacy of the treatment based on a 4-point rating scale "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation.
Time Frame
Up to 24 months
Title
Inhibitor Formation to FVIII
Description
Number of subjects who develop inhibitors to FVIII
Time Frame
Up to 24 months
Title
Annualized Spontaneous Bleeding Rate
Description
The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest).
Time Frame
Up to 24 months
Title
Treatment Success During the Peri-operative Surgical Sub-study
Description
Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator.
Time Frame
From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)
Secondary Outcome Measure Information:
Title
AUC0-∞ (Part 1)
Description
AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion
Title
Cmax (Part 1)
Description
Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion
Title
Tmax (Part 1)
Description
Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion
Title
Half-life (t1/2) (Part 1)
Description
Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion.
Title
Mean Residence Time (MRT) (Part 1)
Description
Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion
Title
Clearance (Cl) (Part 1)
Description
Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion
Title
Volume of Distribution at Steady-state (Vss) (Part 1)
Description
Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Time Frame
Before infusion and at up to 10 time points within 72 hours of infusion
Title
Incremental Recovery (Part 1)
Description
Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.
Time Frame
At 30 minutes after infusion
Title
Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds
Description
The annualized bleeding rate was derived for each subject as follows: 365.25*(number of bleeding episodes requiring treatment) / (observed treatment period of interest).
Time Frame
Up to 24 months
Title
Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis
Description
Percentage of bleeding episodes requiring 1, 2, 3 or > 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes.
Time Frame
During the study (up to 24 months; assessed at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24)
Other Pre-specified Outcome Measures:
Title
Incremental Recovery (Part 3)
Description
Incremental recovery of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.
Time Frame
At 30 minutes after infusion
Title
Volume of Distribution at Steady-state (Vss) (Part 3)
Description
Volume of distribution at steady-state (Vss) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion.
Title
Clearance (Cl) (Part 3)
Description
Clearance (Cl) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion.
Title
Mean Residence Time (MRT) (Part 3)
Description
Mean residence time (MRT) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion.
Title
Half-life (t1/2) (Part 3)
Description
Half-life (t1/2) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion.
Title
Tmax (Part 3)
Description
Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after an initial and repeat infusion of rVIII-SingleChain.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion.
Title
Cmax (Part 3)
Description
Cmax of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion
Title
AUC0-∞ (Part 3)
Description
AUC0-∞ (AUC from 0 extrapolated to infinity) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.
Time Frame
Before infusion and at up to 12 time points within 96 hours of infusion
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records.
Males between 18 and 65 years of age (Parts 1 and 2).
Males between 12 and 65 years of age (Part 3).
Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product
Written informed consent for study participation obtained before undergoing any study specific procedures.
Exclusion Criteria:
Any history of or current FVIII inhibitors
Any first order family history of FVIII inhibitors
Use of an Investigational Medicinal Product within 30 days prior to the first rVIII-SingleChain administration.
Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rVIII-SingleChain or reference product.
Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
Platelet count < 100,000/µL at screening.
Human immunodeficiency virus (HIV) positive subjects with a CD4 count < 200/mm3, in their medical history or at screening if available results are older than one year. (HIV positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the Investigator).
Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening.
Subjects with serum creatinine values > 2 x ULN at Screening.
Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1.
Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Day 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Program Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Study Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Study Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3833
Country
United States
Facility Name
Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Study Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Study Site
City
Nedlands
ZIP/Postal Code
WA 6009
Country
Australia
Facility Name
Study Site
City
Perth
ZIP/Postal Code
WA 6000
Country
Australia
Facility Name
Study Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Study Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Study Site
City
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Study Site
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Study Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Study Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Study Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Study Site
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Study Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Study Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Study Site
City
Heidelberg
ZIP/Postal Code
69123
Country
Germany
Facility Name
Study Site
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Study Site
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Study Site
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Study Site
City
Padova
ZIP/Postal Code
35123
Country
Italy
Facility Name
Study Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Study Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Study Site
City
Kashihara, Nara
Country
Japan
Facility Name
Study Site
City
Kitakyushu, Fukuoka
Country
Japan
Facility Name
Study Site
City
Nagoya
ZIP/Postal Code
466-85660
Country
Japan
Facility Name
Study Site
City
Nishinomiya, Hyogo
Country
Japan
Facility Name
Study Site
City
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Study Site
City
Saitama
Country
Japan
Facility Name
Study Site
City
Suginami-ku, Tokyo
Country
Japan
Facility Name
Study Site
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Study Site
City
Beirut
Country
Lebanon
Facility Name
Study Site
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Study Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Study Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Study Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Study Site
City
Wroclaw
State/Province
Silesia
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Study Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Study Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Study Site
City
Bucharest
ZIP/Postal Code
011026
Country
Romania
Facility Name
Study Site
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
Study Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Study Site
City
Cape Town
ZIP/Postal Code
7295
Country
South Africa
Facility Name
Study Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Study Site
City
Barcelona
Country
Spain
Facility Name
Study Site
City
La Coruna
Country
Spain
Facility Name
Study Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Study Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Study Site
City
Donetsk
ZIP/Postal Code
830045
Country
Ukraine
Facility Name
Study Site
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Study Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27330001
Citation
Mahlangu J, Kuliczkowski K, Karim FA, Stasyshyn O, Kosinova MV, Lepatan LM, Skotnicki A, Boggio LN, Klamroth R, Oldenburg J, Hellmann A, Santagostino E, Baker RI, Fischer K, Gill JC, P'Ng S, Chowdary P, Escobar MA, Khayat CD, Rusen L, Bensen-Kennedy D, Blackman N, Limsakun T, Veldman A, St Ledger K, Pabinger I; AFFINITY Investigators. Efficacy and safety of rVIII-SingleChain: results of a phase 1/3 multicenter clinical trial in severe hemophilia A. Blood. 2016 Aug 4;128(5):630-7. doi: 10.1182/blood-2016-01-687434. Epub 2016 Jun 21.
Results Reference
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An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
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