search
Back to results

A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Primary Purpose

Thrombotic Thrombocytopenic Purpura (TTP)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAK-755
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombotic Thrombocytopenic Purpura (TTP) focused on measuring Drug Therapy, Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Eligibility Criteria

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

Key Inclusion Criteria Participant must provide a signed informed consent form. A fully recognized proxy may be used per local laws for participants unable to provide consent. Participant is 18 years or older at time of screening. Participant has been diagnosed with de novo or relapsed iTTP. Participant must be willing to fully comply with study procedures and requirements. Female participants of childbearing potential must present with a negative pregnancy test and agree to employ highly effective birth control measures for duration of study. Sexually active male participants must agree to use an effective method of contraception for the duration of the study. Key Exclusion Criteria Participant has received more than 2 pre-study PEX prior to randomization. Participant has been diagnosed with cTTP or another cause of thrombotic microangiopathy (TMA). Participant has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical study involving investigational product or investigational device during the course of the study. Participant has received caplacizumab within 30 days prior to study enrollment. Participant has had a previous iTTP event within the past 30 days. Participant is positive for human immunodeficiency virus (HIV) with unstable disease or cluster of differentiation (CD)4+ count ≤200 cells/mm^3 within 3 months of screening. Participant has condition of severe immunodeficiency. Participant has a severe systemic acute infection. Participant has another underlying progressive fatal disease and/or life expectancy <3 months. Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures. Participant is pregnant or lactating. Participant has any condition in which methylprednisolone or other steroid equivalent is contraindicated as per prescribing information. Participant has known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS13, Chinese hamster ovary (CHO) cell proteins, or other constituents of TAK-755.

Sites / Locations

  • University of Florida Shands
  • Brigham and Women's Hospital
  • University if Minnesota Med CARRecruiting
  • Rutgers University
  • Weill Cornell Medical College New York Presbyterian HospitalRecruiting
  • Duke University Medical CenterRecruiting
  • Leo Jenkins Cancer Center/ECU School of MedicineRecruiting
  • Ohio State UniversityRecruiting
  • University of Utah
  • Versiti Clinical Trials and Research Office
  • Clinica Zabala
  • Hospital Universitario Austral
  • AKH- Medizinische Universitat WienRecruiting
  • General Hospital Of Athens LaikoRecruiting
  • University Hospital of PatraRecruiting
  • General Hospital of Thessaloniki "G. Papanikolaou"Recruiting
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
  • Instytut Hematologii i Transfuzjologii
  • Hospital de CrucesRecruiting
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Virgen del RocioRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Hospital Universitario Dr. PesetRecruiting
  • Royal Liverpool University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAK-755 Dose 1 in Acute Phase and Dose 2 in Post-acute Phase

TAK-755 Dose 2 in Both Acute and Post-Acute Phase

Arm Description

TAK-755 Dose 1, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.

TAK-755 Dose 2, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESIs) After Receiving any Dose of Investigational Product (IP)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. SAE: Signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. Adverse events of special interest include thromboembolic events and treatment-related bleeding events.

Secondary Outcome Measures

Achievement of Clinical Response Without On-Study Plasma Exchange (PEX)
Clinical response is defined as normalization of platelets and no clinical evidence of new or progressive ischemic organ injury. Normalization of platelets: First occurrence of normal platelet count (≥150,000/microliter [μL]) that is followed by a confirmatory platelet count of ≥150,000/μL and a lactate dehydrogenase (LDH) <1.5×upper limit of normal (ULN) at 48±12 hours after the first occurrence.
Achievement of Clinical Response With Zero or Minimal on-Study PEX
The number of PEX administered considered Zero when no PEX is administered and considered Minimal when 1 to 3 PEX are administered.
Achievement of Clinical Response Overall
Overall indicates clinical response regardless of whether on-study PEX is administered, or the number of PEX administered.
Time to Clinical Response (Acute Phase)
Occurrence of Refractoriness (Acute Phase)
Time to First On-Study PEX to Achieve Clinical Response
Number of Days of On-study PEX in Participants Who Achieved Clinical Response (Acute Phase)
Total Volume of Plasma Administered (Acute Phase)
Occurrence of Treatment Failure
Treatment failure is defined as failure to achieve or maintain clinical response, including refractory iTTP and recurrent iTTP.
Occurrence of Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) Recurrence, Exacerbation, or Relapse (Post-acute Phase)
iTTP recurrence comprised of exacerbation or relapse. Clinical exacerbation: Occurs <30 days after achieving initial clinical response (i.e., before clinical remission) and recurrent thrombocytopenia (platelet levels <150,000/μL), with or without clinical evidence of new or progressive ischemic organ damage, requiring daily PEX or rescue therapy. Clinical relapses: Occurs ≥30 days after achieving initial clinical response (i.e., after clinical remission) and recurrent thrombocytopenia (platelet levels <150,000/μL), with or without clinical evidence of new or progressive ischemic organ damage, requiring daily PEX or rescue therapy.
Time to iTTP Recurrence, Exacerbation, or Relapse
Occurrence of any one of the following events: Clinical Recurrence, iTTP-Related Death, or Major Thromboembolic Event From Time of First IP Administration Through Study Completion
Time to Occurrence of Any One of the Following Events: Clinical Recurrence, iTTP-Related Death, or Major Thromboembolic Event From Time of First IP Administration Through Study Completion
Change From Baseline in Lactate Dehydrogenase [LDH] Levels at Clinical Response and Study Completion
Change From Baseline in Troponin Levels at Clinical Response and Study Completion
Achievement of Clinical Remission
Clinical remission is defined as achieving and maintaining clinical response for ≥30 days.
A Disintegrin and Metalloproteinase With Thrombospondin Motifs 13 (ADAMTS13) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
ADAMTS13 Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
Von Willebrand Factor (VWF) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
VWF Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases

Full Information

First Posted
January 24, 2023
Last Updated
October 16, 2023
Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05714969
Brief Title
A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Official Title
A Phase 2b, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of TAK-755 (rADAMTS13) With Minimal to No Plasma Exchange (PEX) in the Treatment of Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.

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
This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombotic Thrombocytopenic Purpura (TTP)
Keywords
Drug Therapy, Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAK-755 Dose 1 in Acute Phase and Dose 2 in Post-acute Phase
Arm Type
Experimental
Arm Description
TAK-755 Dose 1, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
Arm Title
TAK-755 Dose 2 in Both Acute and Post-Acute Phase
Arm Type
Experimental
Arm Description
TAK-755 Dose 2, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
Intervention Type
Biological
Intervention Name(s)
TAK-755
Other Intervention Name(s)
rADAMTS13, recombinant ADAMTS13, SHP-655, BAX 930
Intervention Description
TAK-755 IV infusion
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESIs) After Receiving any Dose of Investigational Product (IP)
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. SAE: Signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. Adverse events of special interest include thromboembolic events and treatment-related bleeding events.
Time Frame
Through study completion, approximately 12 weeks
Secondary Outcome Measure Information:
Title
Achievement of Clinical Response Without On-Study Plasma Exchange (PEX)
Description
Clinical response is defined as normalization of platelets and no clinical evidence of new or progressive ischemic organ injury. Normalization of platelets: First occurrence of normal platelet count (≥150,000/microliter [μL]) that is followed by a confirmatory platelet count of ≥150,000/μL and a lactate dehydrogenase (LDH) <1.5×upper limit of normal (ULN) at 48±12 hours after the first occurrence.
Time Frame
Through study completion, approximately 12 weeks
Title
Achievement of Clinical Response With Zero or Minimal on-Study PEX
Description
The number of PEX administered considered Zero when no PEX is administered and considered Minimal when 1 to 3 PEX are administered.
Time Frame
Through study completion, approximately 12 weeks
Title
Achievement of Clinical Response Overall
Description
Overall indicates clinical response regardless of whether on-study PEX is administered, or the number of PEX administered.
Time Frame
Through study completion, approximately 12 weeks
Title
Time to Clinical Response (Acute Phase)
Time Frame
Through study completion, approximately 12 weeks
Title
Occurrence of Refractoriness (Acute Phase)
Time Frame
Through study completion, approximately 12 weeks
Title
Time to First On-Study PEX to Achieve Clinical Response
Time Frame
Through study completion, approximately 12 weeks
Title
Number of Days of On-study PEX in Participants Who Achieved Clinical Response (Acute Phase)
Time Frame
Through study completion, approximately 12 weeks
Title
Total Volume of Plasma Administered (Acute Phase)
Time Frame
Through study completion, approximately 12 weeks
Title
Occurrence of Treatment Failure
Description
Treatment failure is defined as failure to achieve or maintain clinical response, including refractory iTTP and recurrent iTTP.
Time Frame
Through study completion, approximately 12 weeks
Title
Occurrence of Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) Recurrence, Exacerbation, or Relapse (Post-acute Phase)
Description
iTTP recurrence comprised of exacerbation or relapse. Clinical exacerbation: Occurs <30 days after achieving initial clinical response (i.e., before clinical remission) and recurrent thrombocytopenia (platelet levels <150,000/μL), with or without clinical evidence of new or progressive ischemic organ damage, requiring daily PEX or rescue therapy. Clinical relapses: Occurs ≥30 days after achieving initial clinical response (i.e., after clinical remission) and recurrent thrombocytopenia (platelet levels <150,000/μL), with or without clinical evidence of new or progressive ischemic organ damage, requiring daily PEX or rescue therapy.
Time Frame
Through study completion, approximately 12 weeks
Title
Time to iTTP Recurrence, Exacerbation, or Relapse
Time Frame
Through study completion, approximately 12 weeks
Title
Occurrence of any one of the following events: Clinical Recurrence, iTTP-Related Death, or Major Thromboembolic Event From Time of First IP Administration Through Study Completion
Time Frame
Through study completion, approximately 12 weeks
Title
Time to Occurrence of Any One of the Following Events: Clinical Recurrence, iTTP-Related Death, or Major Thromboembolic Event From Time of First IP Administration Through Study Completion
Time Frame
Through study completion, approximately 12 weeks
Title
Change From Baseline in Lactate Dehydrogenase [LDH] Levels at Clinical Response and Study Completion
Time Frame
Through study completion, approximately 12 weeks
Title
Change From Baseline in Troponin Levels at Clinical Response and Study Completion
Time Frame
Through study completion, approximately 12 weeks
Title
Achievement of Clinical Remission
Description
Clinical remission is defined as achieving and maintaining clinical response for ≥30 days.
Time Frame
Through study completion, approximately 12 weeks
Title
A Disintegrin and Metalloproteinase With Thrombospondin Motifs 13 (ADAMTS13) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
Time Frame
Through study completion, approximately 12 weeks
Title
ADAMTS13 Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
Time Frame
Through study completion, approximately 12 weeks
Title
Von Willebrand Factor (VWF) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
Time Frame
Through study completion, approximately 12 weeks
Title
VWF Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
Time Frame
Through study completion, approximately 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Participant must provide a signed informed consent form. A fully recognized proxy may be used per local laws for participants unable to provide consent. Participant is 18 years or older at time of screening. Participant has been diagnosed with de novo or relapsed iTTP. Participant must be willing to fully comply with study procedures and requirements. Female participants of childbearing potential must present with a negative pregnancy test and agree to employ highly effective birth control measures for duration of study. Sexually active male participants must agree to use an effective method of contraception for the duration of the study. Key Exclusion Criteria Participant has received more than 2 pre-study PEX prior to randomization. Participant has been diagnosed with cTTP or another cause of thrombotic microangiopathy (TMA). Participant has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical study involving investigational product or investigational device during the course of the study. Participant has received caplacizumab within 30 days prior to study enrollment. Participant has had a previous iTTP event within the past 30 days. Participant is positive for human immunodeficiency virus (HIV) with unstable disease or cluster of differentiation (CD)4+ count ≤200 cells/mm^3 within 3 months of screening. Participant has condition of severe immunodeficiency. Participant has a severe systemic acute infection. Participant has another underlying progressive fatal disease and/or life expectancy <3 months. Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures. Participant is pregnant or lactating. Participant has any condition in which methylprednisolone or other steroid equivalent is contraindicated as per prescribing information. Participant has known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS13, Chinese hamster ovary (CHO) cell proteins, or other constituents of TAK-755.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
352-262-7165
Email
ZUMBEMS@medicine.efl.edu
First Name & Middle Initial & Last Name & Degree
Marc Zumberg
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-732-5840
Email
alanger@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Arielle Langer
Facility Name
University if Minnesota Med CAR
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
612-626-3757
Email
verce001@umn.edu
First Name & Middle Initial & Last Name & Degree
Gregory Vercellotti
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
732-235-7678
Email
as2872@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Ashwin Sridharan
Facility Name
Weill Cornell Medical College New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
646-962-2065
Email
mtd2002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Maria De Sancho
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
919-684-5350
Email
thomas.ortel@duke.edu
First Name & Middle Initial & Last Name & Degree
Thomas Ortel
Facility Name
Leo Jenkins Cancer Center/ECU School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
252-744-3556
Email
lilesd@ecu.edu
First Name & Middle Initial & Last Name & Degree
Darla Liles
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
614-293-2887
Email
spero.cataland@osumc.edu
First Name & Middle Initial & Last Name & Degree
Spero Cataland
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
801-585-2626
Email
yazan.abou-ismail@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Yazan Abou-Ismail
Facility Name
Versiti Clinical Trials and Research Office
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
414-937-6826
Email
lisakreuziger@versiti.org
First Name & Middle Initial & Last Name & Degree
Lisa Baumann Kreuziger
Facility Name
Clinica Zabala
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
5491162650104
Email
hhferro@gmail.com
First Name & Middle Initial & Last Name & Degree
Hugo Ferro
Facility Name
Hospital Universitario Austral
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
541147085000
Email
emicarricondo@gmail.com
First Name & Middle Initial & Last Name & Degree
Silvio Ariel Emiliano Carricondo
Facility Name
AKH- Medizinische Universitat Wien
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
4314040044100
Email
paul.knobl@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Paul Knobl
Facility Name
General Hospital Of Athens Laiko
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
302132060961
Email
ppanayi@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Panayiotis Panayiotidis
Facility Name
University Hospital of Patra
City
Patra
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
302613603247
Email
argiris.symeonidis@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Anargyros Symeoinidis
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou"
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
302313307533
Email
ioannamarilena@gmail.com
First Name & Middle Initial & Last Name & Degree
Ionna Sakellari
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
390255035414
Email
flora.peyvandi@policlinico.mi.it
First Name & Middle Initial & Last Name & Degree
Flora Peyvandi
Facility Name
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
116335329
Email
aborchiellini@cittadeallasalute.to.it
First Name & Middle Initial & Last Name & Degree
Alessandra Borchiellini
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
482234961581
Email
jwindyga@ihit.waw.pl
First Name & Middle Initial & Last Name & Degree
Jerzy Windyga
Facility Name
Hospital de Cruces
City
Barakaldo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
34946006000
Email
miriam.varapampliega@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Miriam Vara Pampliega
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
34915868443
Email
crisizquierdo3@yahoo.es
First Name & Middle Initial & Last Name & Degree
Cristina Pascual Izquierdo
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
34955013260
Email
mariae.mingot.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Maria Eva Mingot Castellano
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
34961245875
Email
delarubia_jav@gva.es
First Name & Middle Initial & Last Name & Degree
Javier de la rubia
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
34963189168
Email
fernandez_migzar@gva.es
First Name & Middle Initial & Last Name & Degree
Miguel Fernandez Zarzoso
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
441517063397
Email
tina.dutt@liverpoolft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Tina Dutt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Time Frame
NOTE: IPD Sharing Time Frame has not been entered.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

We'll reach out to this number within 24 hrs