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An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

Primary Purpose

Hemophilia A, Severe Hemophilia A

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rVIII-SingleChain
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

PTPs:

  • Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
  • Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.

PUPs:

  • Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%)
  • No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).

ITI substudy:

  • PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.

Exclusion Criteria:

  • Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
  • Currently receiving a therapy not permitted during the study.
  • Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal at Screening (if specified)
  • Any first-order family (eg, siblings) history of FVIII inhibitors
  • For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors

Sites / Locations

  • Study Site 8400213
  • Study Site 8400241
  • Study Site 8400118
  • Study Site 8400116
  • Study Site 8400184
  • Study Site 8400204
  • Study Site 8400240
  • Study Site 8400041
  • Study Site 8400154
  • Study Site 0360014
  • Study Site 0360028
  • Study Site 0360031
  • Study Site 0400012
  • Study Site 0400003
  • Study Site 0400001
  • Study Site 0400002
  • Study Site 1240022
  • Study Site 2030017
  • Study Site 2500015
  • Study Site 2500017
  • Study Site 2500028
  • Study Site 2500018
  • Study Site 2500002
  • Study Site 2680001
  • Study Site 2760034
  • Study Site 2760091
  • Study Site 2760087
  • Study Site 2760066
  • Study Site 3480007
  • Study Site 3720002
  • Study Site 3800023
  • Study Site 3920031
  • Study Site 3920029
  • Study Site 3920064
  • Study Site 3920033
  • Study Site 3920025
  • Study Site 4220007
  • Study Site 4580001
  • Study Site 5280006
  • Study Site 5280008
  • Study Site 5280007
  • Study Site 6080001
  • Study Site 6080002
  • Study Site 6160013
  • Study Site 6160038
  • Study Site 6160035
  • Study Site 6160014
  • Study Site 6200001
  • Study Site 6420030
  • Study Site 6420037
  • Study Site 7100001
  • Study Site 7240008
  • Study Site 7240021
  • Study Site 7240007
  • Study Site 7240023
  • Study Site 7560010
  • Study Site 7640001
  • Study Site 7640005
  • Study Site 7640002
  • Study Site 7640004
  • Study Site 7640003
  • Study Site 8040007
  • Study Site 8040005
  • Study Site 8260008

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Previously treated patients (PTPs)

Previously untreated patients (PUPs)

Arm Description

The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available.

The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.

Outcomes

Primary Outcome Measures

Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627
Number of Previously Untreated Patients (PUPs) With High-titer Inhibitor Formation to FVIII With at Least 50 EDs to CSL627
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Percent Treatment Success for Major Bleeding Episodes in PUPs
Percentage of major bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Major bleeding episodes are defined as bleeding episodes for which a subject is required to seek treatment at the hemophilia center or that threatens the subject's life or loss of limb.
Annualized Spontaneous Bleeding Rate in PUPs
The annualized spontaneous bleeding rate for PUPs taking prophylaxis and on-demand treatment regimens.

Secondary Outcome Measures

Percentage of Bleeding Episodes Treated Successfully in PTPs
Percentage of bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response".
Annualized Bleeding Rate in PTPs and PUPs
The annualized bleeding rate for PTPs and PUPs taking prophylaxis and on-demand treatment regimens
Percentage of Bleeding Episodes Requiring 1, 2, 3, or > 3 Injections of CSL627 to Achieve Hemostasis in PTPs and PUPs
Mean Number of On-demand Infusions of CSL627
Mean On-demand Dose Administered of CSL627
Mean Prophylaxis Dose Administered of CSL627
Mean Total Amount of CSL627 Administered During Surgery Period in PTPs
Total Amount of CSL627 Administered During Surgery Period in PUPs
Hemostatic Efficacy of rVIII-SingleChain for PTPs and PUPs Who Undergo Surgery
The investigator will rate the efficacy of the rVIII-SingleChain treatment during surgery based on a hemostatic efficacy four point rating scale of "excellent, good, moderate or poor/no response".
Incidence of Inhibitor Formation to FVIII in PTPs After 10 EDs and After 50 EDs
Percentage of PTPs and PUPs Developing Antibodies Against CSL627
Percentage of PTPs and PUPs Developing Antibodies to Chinese Hamster Ovary (CHO) Proteins
Number of PUPs With High-titer Inhibitor Formation to FVIII After 10 EDs With CSL627
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Number of PUPs With Low-titer Inhibitor Formation to FVIII After 10 EDs and After 50 EDs With CSL627
Low-titer inhibitor is defined as an inhibitor titer of less than 5 Bethesda units/mL.
Incidence of Total Inhibitor Formation to FVIII in PUPs
Percent Treatment Success for Non-major Bleeding Episodes in PUPs
Percentage of bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Non-major bleeding episodes are those not requiring treatment at the hemophilia center or not threatening subject's life or loss of limb.
Percentage of PUPs With Clinically Significant Abnormal Vital Signs Values After First Infusion of CSL627
Vital signs assessments include heart rate, blood pressure, and body temperature. Clinical significance of an abnormality will be assessed by the investigator.
Percentage of PUPs With Treatment-emergent Clinically Significant Abnormal Vital Signs Values
Vital signs assessments include heart rate, blood pressure, and body temperature. Clinical significance of an abnormality will be assessed by the investigator.

Full Information

First Posted
June 23, 2014
Last Updated
September 29, 2021
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT02172950
Brief Title
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
Official Title
A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (undefined)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
January 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A, Severe Hemophilia A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Previously treated patients (PTPs)
Arm Type
Experimental
Arm Description
The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available.
Arm Title
Previously untreated patients (PUPs)
Arm Type
Experimental
Arm Description
The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics.
Intervention Type
Biological
Intervention Name(s)
rVIII-SingleChain
Other Intervention Name(s)
CSL627
Intervention Description
Recombinant single-chain coagulation factor VIII
Primary Outcome Measure Information:
Title
Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627
Time Frame
At the closest visit after 100 EDs (up to 5 years).
Title
Number of Previously Untreated Patients (PUPs) With High-titer Inhibitor Formation to FVIII With at Least 50 EDs to CSL627
Description
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Time Frame
At the closest visit after 50 EDs (up to 5 years).
Title
Percent Treatment Success for Major Bleeding Episodes in PUPs
Description
Percentage of major bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Major bleeding episodes are defined as bleeding episodes for which a subject is required to seek treatment at the hemophilia center or that threatens the subject's life or loss of limb.
Time Frame
Up to 5 years
Title
Annualized Spontaneous Bleeding Rate in PUPs
Description
The annualized spontaneous bleeding rate for PUPs taking prophylaxis and on-demand treatment regimens.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Percentage of Bleeding Episodes Treated Successfully in PTPs
Description
Percentage of bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response".
Time Frame
Up to 5 years
Title
Annualized Bleeding Rate in PTPs and PUPs
Description
The annualized bleeding rate for PTPs and PUPs taking prophylaxis and on-demand treatment regimens
Time Frame
Up to 5 years
Title
Percentage of Bleeding Episodes Requiring 1, 2, 3, or > 3 Injections of CSL627 to Achieve Hemostasis in PTPs and PUPs
Time Frame
Up to 5 years
Title
Mean Number of On-demand Infusions of CSL627
Time Frame
Up to 5 years
Title
Mean On-demand Dose Administered of CSL627
Time Frame
Up to 5 years
Title
Mean Prophylaxis Dose Administered of CSL627
Time Frame
Up to 5 years
Title
Mean Total Amount of CSL627 Administered During Surgery Period in PTPs
Time Frame
Day of surgery up to 336 hours post-surgery
Title
Total Amount of CSL627 Administered During Surgery Period in PUPs
Time Frame
Day of surgery up to 336 hours post-surgery
Title
Hemostatic Efficacy of rVIII-SingleChain for PTPs and PUPs Who Undergo Surgery
Description
The investigator will rate the efficacy of the rVIII-SingleChain treatment during surgery based on a hemostatic efficacy four point rating scale of "excellent, good, moderate or poor/no response".
Time Frame
From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)
Title
Incidence of Inhibitor Formation to FVIII in PTPs After 10 EDs and After 50 EDs
Time Frame
Up to 5 years
Title
Percentage of PTPs and PUPs Developing Antibodies Against CSL627
Time Frame
PTPs: At the closest visit after 100 EDs (up to 5 years). PUPs: At the closest visit after 50 EDs (up to 5 years).
Title
Percentage of PTPs and PUPs Developing Antibodies to Chinese Hamster Ovary (CHO) Proteins
Time Frame
PTPs: At the closest visit after 100 EDs (up to 5 years). PUPs: At the closest visit after 50 EDs (up to 5 years).
Title
Number of PUPs With High-titer Inhibitor Formation to FVIII After 10 EDs With CSL627
Description
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Time Frame
At the closest visit after 10 EDs (up to 5 years)
Title
Number of PUPs With Low-titer Inhibitor Formation to FVIII After 10 EDs and After 50 EDs With CSL627
Description
Low-titer inhibitor is defined as an inhibitor titer of less than 5 Bethesda units/mL.
Time Frame
At the closest visit after 10 and after 50 EDs (up to 5 years)
Title
Incidence of Total Inhibitor Formation to FVIII in PUPs
Time Frame
Up to 5 years
Title
Percent Treatment Success for Non-major Bleeding Episodes in PUPs
Description
Percentage of bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Non-major bleeding episodes are those not requiring treatment at the hemophilia center or not threatening subject's life or loss of limb.
Time Frame
Up to 5 years
Title
Percentage of PUPs With Clinically Significant Abnormal Vital Signs Values After First Infusion of CSL627
Description
Vital signs assessments include heart rate, blood pressure, and body temperature. Clinical significance of an abnormality will be assessed by the investigator.
Time Frame
Up to 6 hours after first infusion
Title
Percentage of PUPs With Treatment-emergent Clinically Significant Abnormal Vital Signs Values
Description
Vital signs assessments include heart rate, blood pressure, and body temperature. Clinical significance of an abnormality will be assessed by the investigator.
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PTPs: Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain. Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain. PUPs: Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%) No prior exposure to any Factor VIII product (with the exception of short-term use of blood products). ITI substudy: PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study. Exclusion Criteria: Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins. Currently receiving a therapy not permitted during the study. Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal at Screening (if specified) Any first-order family (eg, siblings) history of FVIII inhibitors For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors
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 8400213
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8651
Country
United States
Facility Name
Study Site 8400241
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Study Site 8400118
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Study Site 8400116
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Study Site 8400184
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Study Site 8400204
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Study Site 8400240
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
Study Site 8400041
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Study Site 8400154
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Study Site 0360014
City
Melbourne
ZIP/Postal Code
3052
Country
Australia
Facility Name
Study Site 0360028
City
Nedlands
ZIP/Postal Code
WA 6009
Country
Australia
Facility Name
Study Site 0360031
City
Perth
ZIP/Postal Code
WA 6000
Country
Australia
Facility Name
Study Site 0400012
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Study Site 0400003
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Study Site 0400001
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Study Site 0400002
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Study Site 1240022
City
Saint John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Study Site 2030017
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Study Site 2500015
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Study Site 2500017
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Study Site 2500028
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Study Site 2500018
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Study Site 2500002
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Study Site 2680001
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Study Site 2760034
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Study Site 2760091
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Study Site 2760087
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Study Site 2760066
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Study Site 3480007
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Study Site 3720002
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Study Site 3800023
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Study Site 3920031
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Study Site 3920029
City
Nagoya
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Study Site 3920064
City
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Study Site 3920033
City
Saitama
ZIP/Postal Code
339-8551
Country
Japan
Facility Name
Study Site 3920025
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Study Site 4220007
City
Beirut
ZIP/Postal Code
165191
Country
Lebanon
Facility Name
Study Site 4580001
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Study Site 5280006
City
Amsterdam Zuidoost
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Study Site 5280008
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands
Facility Name
Study Site 5280007
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Study Site 6080001
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Study Site 6080002
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Study Site 6160013
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Study Site 6160038
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Study Site 6160035
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Study Site 6160014
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Study Site 6200001
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Study Site 6420030
City
Bucharest
ZIP/Postal Code
011026
Country
Romania
Facility Name
Study Site 6420037
City
Timisoara
ZIP/Postal Code
300011
Country
Romania
Facility Name
Study Site 7100001
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Study Site 7240008
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Study Site 7240021
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Study Site 7240007
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Study Site 7240023
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Study Site 7560010
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Study Site 7640001
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Study Site 7640005
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Study Site 7640002
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Study Site 7640004
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Study Site 7640003
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Study Site 8040007
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Study Site 8040005
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Study Site 8260008
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

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