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Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

Primary Purpose

Acute Intracranial Hemorrhage

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
andexanet alfa
Usual Care
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Intracranial Hemorrhage focused on measuring thrombosis, anticoagulant, acute intracranial hemorrhage, andexanet alfa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent. Either the patient or his or her medical proxy (or legally authorized representative if permissible by local or regional laws and regulations) has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening.

    • Deferred consent procedure is allowed where approved by local ethics committees. In cases of deferred consent, the time of the study physician's documented decision to include the patient into the study will serve as "time of consent" with respect to protocol-specific procedures.
    • In all cases where the patient does not sign informed consent prior to study entry, informed consent from the patient will be obtained as soon as realistically possible after inclusion in the trial and in accordance with the Declaration of Helsinki, International Conference on Harmonization-Good Clinical Practice (GCP), the Data Protection Directive (Directive 95/46/EC) and national and local regulations.
  2. Age ≥ 18 years old at the time of consent.
  3. An acute intracerebral bleeding episode, defined as an estimated blood volume ≥ 0.5 to ≤ 60 mL acutely observed radiographically within the cerebrum. Patients may have extracerebral (e.g., subdural, subarachnoid, epidural) or extracranial (e.g., gastrointestinal, intraspinal) bleeding additionally, but the intracerebral hemorrhage must be considered the most clinically significant bleed at the time of enrollment.
  4. Performance of a head CT or MRI scan demonstrating the intracerebral bleeding within 2 hours prior to randomization (the baseline scan may be repeated only once to meet this criterion).
  5. Treatment with an oral FXa inhibitor (apixaban [last dose 2.5 mg or greater], rivaroxaban [last dose 10 mg or greater], edoxaban [last dose 30 mg or greater], or enoxaparin [last dose 1 mg or greater]):

    • ≤ 15 hours prior to randomization.
    • > 15 hours prior to randomization or unknown time of last dose, if documented anti fXa activity is > 100 ng/mL for direct fXa inhibitors (apixaban, rivaroxaban or edoxaban) or > 0.5 IU/mL for enoxaparin may be enrolled, irrespective of the time of the last dose, and the patient is within 2 hours prior to consent. Note: Patients enrolled in this manner should receive a high andexanet dosing regimen.
  6. Time from bleeding symptom onset < 6 hours prior to the baseline imaging scan. Time of trauma (if applicable) or time last seen normal may be used as surrogates for time of symptom onset. (If the baseline scan is repeated to meet Inclusion Criterion #4, the time from bleeding symptom onset must be < 6 hours prior to the repeat baseline imaging scan.)
  7. Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified guidance for avoiding pregnancy for 30 days after the last dose of study drug.
  8. Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential).
  9. NIHSS score ≤ 35 at the time of consent. Exclusion Criteria

If a patient meets any of the following criteria, he or she is not eligible to participate in this trial:

  1. Planned surgery, including Burr holes for hematoma drainage, within 12 hours after randomization. Minimally invasive surgery/procedures not directly related to the treatment of intracranial bleeding and that are not expected to significantly affect hematoma volume are allowed (e.g., Burr holes for intracranial pressure monitoring, endoscopy, bronchoscopy, central lines.
  2. GCS score < 7 at the time of consent. If a patient is intubated and/or sedated at the time of consent, they may be enrolled if it can be documented that they were intubated/sedated for non-neurologic reasons within 2 hours prior to consent.
  3. Purposefully left blank.
  4. Anticipation that the baseline and follow up brain scans will not be able to use the same imaging modalities (i.e., patients with a baseline CT scan should have a CT scan in follow up; similarly, for MRI).
  5. Expected survival of less than 1 month (not related to the intracranial bleed).
  6. Recent history (within 2 weeks) of a diagnosed TE or clinically relevant symptoms of the following:

    ○ Venous Thromboembolism (VTE: e.g., deep venous thrombosis, PE, cerebral venous thrombosis), myocardial infarction (MI), Disseminated Intravascular Coagulation (DIC), cerebral vascular accident, transient ischemic attack (TIA), acute coronary syndrome, or arterial systemic embolism.

  7. Acute decompensated heart failure or cardiogenic shock at the time of randomization.
  8. Severe sepsis or septic shock at the time of randomization.
  9. The patient is a pregnant or lactating female.
  10. Receipt of any of the following drugs or blood products within 7 days prior to consent:

    1. VKA (e.g., warfarin).
    2. Dabigatran.
    3. PCC (e.g., KCentra®) or rfVIIa (e.g., NovoSeven®), or anti-inhibitor coagulant complex (e.g., FEIBA®), FFP, and whole blood.
  11. Past use of andexanet (or planned use of commercial andexanet).
  12. Treatment with an investigational drug < 30 days prior to consent.
  13. Any tumor-related bleeding.
  14. Known hypersensitivity to any component of andexanet.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

andexanet alfa

Usual Care

Arm Description

Patients will receive one of two dosing regimens of andexanet alfa based on which FXa inhibitor they received and the amount and timing of the most recent dose.

Usual care will consist of any treatment(s) (including no treatment) other than andexanet alfa administered within 3 hours post-randomization that the Investigator and/or other treating physicians consider to be appropriate.

Outcomes

Primary Outcome Measures

To evaluate the effect of andexanet alfa (andexanet) versus usual care on the rate of effective hemostasis.
Effective haemostasis is defined as change from baseline NIHSS of +6 or less at the 12 hour timepoint AND ≤35% increase in haematoma volume compared to baseline on a repeat CT or MRI scan at 12hrs AND no rescue therapies administered between 3 hours and 12 hours after randomization.

Secondary Outcome Measures

To evaluate the effect of andexanet versus usual care on anti-fXa activity.
Percent change from baseline to nadir in anti-fXa activity during the first 2 hours post-randomization

Full Information

First Posted
August 30, 2018
Last Updated
September 11, 2023
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT03661528
Brief Title
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
Official Title
A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
May 27, 2023 (Actual)
Study Completion Date
August 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant
Detailed Description
This is a randomized, multicenter clinical trial designed to determine the efficacy and safety of andexanet alfa compared to usual care in patients presenting with acute intracranial hemorrhage within 6 hours of symptom onset to baseline scan and within 15 hours of taking an oral factor Xa inhibitor. The study will use a prospective, randomized, open label (PROBE) design. The primary efficacy outcome will be adjudicated by a blinded Endpoint Adjudication Committee. To support the adjudication of hemostatic efficacy, a blinded Imaging Core Laboratory will review all available scans. Between 900 and 1200 patients are planned to be enrolled in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Intracranial Hemorrhage
Keywords
thrombosis, anticoagulant, acute intracranial hemorrhage, andexanet alfa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
ANNEXA-I is a randomized, open-label study with blinded adjudication on primary efficacy and safety outcomes, including death and thrombotic events.
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
andexanet alfa
Arm Type
Experimental
Arm Description
Patients will receive one of two dosing regimens of andexanet alfa based on which FXa inhibitor they received and the amount and timing of the most recent dose.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual care will consist of any treatment(s) (including no treatment) other than andexanet alfa administered within 3 hours post-randomization that the Investigator and/or other treating physicians consider to be appropriate.
Intervention Type
Drug
Intervention Name(s)
andexanet alfa
Intervention Description
Andexanet alfa is a recombinant version of human FXa
Intervention Type
Drug
Intervention Name(s)
Usual Care
Intervention Description
Usual care will consist of any treatment(s) (including no treatment) other than andexanet alfa administered within 3 hours post-randomization that the Investigator and/or other treating physicians consider to be appropriate.
Primary Outcome Measure Information:
Title
To evaluate the effect of andexanet alfa (andexanet) versus usual care on the rate of effective hemostasis.
Description
Effective haemostasis is defined as change from baseline NIHSS of +6 or less at the 12 hour timepoint AND ≤35% increase in haematoma volume compared to baseline on a repeat CT or MRI scan at 12hrs AND no rescue therapies administered between 3 hours and 12 hours after randomization.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
To evaluate the effect of andexanet versus usual care on anti-fXa activity.
Description
Percent change from baseline to nadir in anti-fXa activity during the first 2 hours post-randomization
Time Frame
1-2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. Either the patient or his or her medical proxy (or legally authorized representative if permissible by local or regional laws and regulations) has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening. Deferred consent procedure is allowed where approved by local ethics committees. In cases of deferred consent, the time of the study physician's documented decision to include the patient into the study will serve as "time of consent" with respect to protocol-specific procedures. In all cases where the patient does not sign informed consent prior to study entry, informed consent from the patient will be obtained as soon as realistically possible after inclusion in the trial and in accordance with the Declaration of Helsinki, International Conference on Harmonization-Good Clinical Practice (GCP), the EU General Data Protection Regulation (GDPR) and national and local regulations. Age ≥ 18 years old at the time of consent. An acute intracerebral bleeding episode, defined as an estimated blood volume ≥ 0.5 to ≤ 60 mL acutely observed radiographically within the cerebrum. Patients may have extracerebral (e.g., subdural, subarachnoid, epidural) or extracranial (e.g., gastrointestinal, intraspinal) bleeding additionally, but the intracerebral hemorrhage must be considered the most clinically significant bleed at the time of enrollment. Performance of a head CT or MRI scan demonstrating the intracerebral bleeding within 2 hours prior to randomization (the baseline scan may be repeated only once to meet this criterion). Treatment with an oral FXa inhibitor (apixaban [last dose 2.5 mg or greater], rivaroxaban [last dose 10 mg or greater], or edoxaban [last dose 30 mg or greater]): ≤ 15 hours prior to randomization. > 15 hours prior to randomization or unknown time of last dose, if documented anti fXa activity is > 100 ng/mL for direct fXa inhibitors (apixaban, rivaroxaban or edoxaban) may be enrolled, irrespective of the time of the last dose, and the local anti-fXa activity level is obtained within 2 hours prior to consent, performed as per standard of care. Note: Patients enrolled in this manner should receive a high andexanet dosing regimen. Time from bleeding symptom onset < 6 hours prior to the baseline imaging scan. Time of trauma (if applicable) or time last seen normal may be used as surrogates for time of symptom onset. (If the baseline scan is repeated to meet Inclusion Criterion #4, the time from bleeding symptom onset must be < 6 hours prior to the repeat baseline imaging scan.) Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified guidance for avoiding pregnancy for 30 days after the last dose of study drug. Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential). NIHSS score ≤ 35 at the time of consent. Exclusion Criteria If a patient meets any of the following criteria, he or she is not eligible to participate in this trial: Planned surgery, including Burr holes for hematoma drainage, within 12 hours after randomization. Minimally invasive surgery/procedures not directly related to the treatment of intracranial bleeding and that are not expected to significantly affect hematoma volume are allowed (e.g., Burr holes for intracranial pressure monitoring, endoscopy, bronchoscopy, central lines. GCS score < 7 at the time of consent. If a patient is intubated and/or sedated at the time of consent, they may be enrolled if it can be documented that they were intubated/sedated for non-neurologic reasons within 2 hours prior to consent. Purposefully left blank. Anticipation that the baseline and follow up brain scans will not be able to use the same imaging modalities (i.e., patients with a baseline CT scan should have a CT scan in follow up; similarly, for MRI). Expected survival of less than 1 month (not related to the intracranial bleed). Recent history (within 2 weeks) of a diagnosed TE or clinically relevant symptoms of the following: ○ Venous Thromboembolism (VTE: e.g., deep venous thrombosis, PE, cerebral venous thrombosis), myocardial infarction (MI), Disseminated Intravascular Coagulation (DIC), cerebral vascular accident, transient ischemic attack (TIA), acute coronary syndrome, or arterial systemic embolism. Acute decompensated heart failure or cardiogenic shock at the time of randomization. Severe sepsis or septic shock at the time of randomization. The patient is a pregnant or lactating female. Receipt of any of the following drugs or blood products within 7 days prior to consent: VKA (e.g., warfarin). Dabigatran. PCC (e.g., KCentra®) or rfVIIa (e.g., NovoSeven®), or anti-inhibitor coagulant complex (e.g., FEIBA®), FFP, and whole blood. Past use of andexanet (or planned use of commercial andexanet). Treatment with an investigational drug < 30 days prior to consent. Any tumor-related bleeding. Known hypersensitivity to any component of andexanet.
Facility Information:
Facility Name
Clinical Trial Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Clinical Trial Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Clinical Trial Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Clinical Trial Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Trial Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Clinical Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Clinical Trial Site
City
Mangonia Park
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Clinical Trial Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Clinical Trial Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Clinical Trial Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Clinical Trial Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Clinical Trial Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Clinical Trial Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Clinical Trial Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Clinical Trial Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Clinical Trial Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Clinical Trial Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Clinical Trial Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Clinical Trial Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Clinical Trial Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Clinical Trial Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Clinical Trial Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Trial Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Clinical Trial Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Clinical Trial Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Clinical Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Clinical Trial Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Clinical Trial Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Clinical Trial Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Clinical Trial Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Clinical Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Clinical Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Clinical Trial Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Clinical Trial Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Clinical Trial Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Clinical Trial Site
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Clinical Trial Site
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Clinical Trial Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Clinical Trial Site
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Clinical Trial Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Clinical Trial Site
City
Brugge
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinical Trial Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Clinical Trial Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Clinical Trial Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Clinical Trial Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinical Trial Site
City
Ostend
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Clinical Trial Site
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Clinical Trial Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Clinical Trial Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Clinical Trial Site
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Clinical Trial Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Clinical Trial Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Clinical Trial Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Clinical Trial Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A2B4
Country
Canada
Facility Name
Clinical Trial Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Clinical Trial Site
City
QC
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Clinical Trial Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Clinical Trial Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Clinical Trial Site
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Clinical Trial Site
City
Ostrava
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Clinical Trial Site
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Clinical Trial Site
City
Prague
ZIP/Postal Code
169 02
Country
Czechia
Facility Name
Clinical Trial Site
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Clinical Trial Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Clinical Trial Site
City
Copenhagen
ZIP/Postal Code
DK-2600
Country
Denmark
Facility Name
Clinical Trial Site
City
Glostrup Municipality
ZIP/Postal Code
2400 NV
Country
Denmark
Facility Name
Clinical Trial Site
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Clinical Trial Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Clinical Trial Site
City
Turku
ZIP/Postal Code
FI-20521
Country
Finland
Facility Name
Clinical Trial Site
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Clinical Trial Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Clinical Trial Site
City
Bourg-en-Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Clinical Trial Site
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Clinical Trial Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Clinical Trial Site
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Clinical Trial Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Clinical Trial Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Clinical Trial Site
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
Clinical Trial Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Clinical Trial Site
City
Altenburg
ZIP/Postal Code
04600
Country
Germany
Facility Name
Clinical Trial Site
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Clinical Trial Site
City
Bad Neustadt An Der Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Clinical Trial Site
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Clinical Trial Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Clinical Trial Site
City
Bremen
ZIP/Postal Code
28755
Country
Germany
Facility Name
Clinical Trial Site
City
Chemnitz
ZIP/Postal Code
09166
Country
Germany
Facility Name
Clinical Trial Site
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Clinical Trial Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Clinical Trial Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Clinical Trial Site
City
Essen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Clinical Trial Site
City
Frankfurt am main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Clinical Trial Site
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Clinical Trial Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Clinical Trial Site
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Clinical Trial Site
City
Hamburg
ZIP/Postal Code
22307
Country
Germany
Facility Name
Clinical Trial Site
City
Hamburg
ZIP/Postal Code
81377
Country
Germany
Facility Name
Clinical Trial Site
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Clinical Trial Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Clinical Trial Site
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Clinical Trial Site
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Clinical Trial Site
City
Lünen
ZIP/Postal Code
44534
Country
Germany
Facility Name
Clinical Trial Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Clinical Trial Site
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Clinical Trial Site
City
Murnau am Staffelsee
ZIP/Postal Code
82418
Country
Germany
Facility Name
Clinical Trial Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinical Trial Site
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Clinical Trial Site
City
Sanderbusch
ZIP/Postal Code
26452
Country
Germany
Facility Name
Clinical Trial Site
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Clinical Trial Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Clinical Trial Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Clinical Trial Site
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Clinical Trial Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Clinical Trial Site
City
Heraklion
ZIP/Postal Code
71003
Country
Greece
Facility Name
Clinical Trial Site
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Clinical Trial Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Clinical Trial Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Clinical Trial Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Clinical Trial Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Clinical Trial Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Clinical Trial Site
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Clinical Trial Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Clinical Trial Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Clinical Trial Site
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Clinical Trial Site
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Clinical Trial Site
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Clinical Trial Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Clinical Trial Site
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Clinical Trial Site
City
Jerusalem
ZIP/Postal Code
92100
Country
Israel
Facility Name
Clinical Trial Site
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Clinical Trial Site
City
Tel Aviv-Yafo
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Clinical Trial Site
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Clinical Trial Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Clinical Trial Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Clinical Trial Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Clinical Trial Site
City
Monza
ZIP/Postal Code
I-20900
Country
Italy
Facility Name
Clinical Trial Site
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Clinical Trial Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Clinical Trial Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Clinical Trial Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Clinical Trial Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Clinical Trial Site
City
Siena
ZIP/Postal Code
I-53100
Country
Italy
Facility Name
Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Clinical Trial Site
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Clinical Trial Site
City
Vilnius
ZIP/Postal Code
04130
Country
Lithuania
Facility Name
Clinical Trial Site
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Clinical Trial Site
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Clinical Trial Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Clinical Trial Site
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
Clinical Trial Site
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
Clinical Trial Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Clinical Trial Site
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Clinical Trial Site
City
Trondheim
ZIP/Postal Code
N-7006
Country
Norway
Facility Name
Clinical Trial Site
City
Gdańsk
ZIP/Postal Code
80 - 803
Country
Poland
Facility Name
Clinical Trial Site
City
Gmina Końskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Clinical Trial Site
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Clinical Trial Site
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Clinical Trial Site
City
Krakow
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Clinical Trial Site
City
Kraków
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Clinical Trial Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Clinical Trial Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Clinical Trial Site
City
Sandomierz
ZIP/Postal Code
27-600
Country
Poland
Facility Name
Clinical Trial Site
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Clinical Trial Site
City
Warsaw
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Clinical Trial Site
City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
Facility Name
Clinical Trial Site
City
Wrocław
ZIP/Postal Code
54-049
Country
Poland
Facility Name
Clinical Trial Site
City
Coimbra
State/Province
Centro Region
ZIP/Postal Code
3000-75
Country
Portugal
Facility Name
Clinical Trial Site
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Clinical Trial Site
City
Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Clinical Trial Site
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Clinical Trial Site
City
Lisbon
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Clinical Trial Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Clinical Trial Site
City
Senhora da Hora
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Clinical Trial Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Clinical Trial Site
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Clinical Trial Site
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Clinical Trial Site
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Clinical Trial Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Clinical Trial Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Clinical Trial Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinical Trial Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Clinical Trial Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Clinical Trial Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Clinical Trial Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Clinical Trial Site
City
Göteborg
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Clinical Trial Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Clinical Trial Site
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Clinical Trial Site
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Clinical Trial Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Clinical Trial Site
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Clinical Trial Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Clinical Trial Site
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
Facility Name
Clinical Trial Site
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Clinical Trial Site
City
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Clinical Trial Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Clinical Trial Site
City
London
ZIP/Postal Code
WC1B 5EH
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Nottingham
ZIP/Postal Code
NG12 3EL
Country
United Kingdom
Facility Name
Clinical Trial Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

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