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Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

Primary Purpose

Warm Autoimmune Hemolytic Anemia (wAIHA)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rilzabrutinib
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warm Autoimmune Hemolytic Anemia (wAIHA)

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female patients with a confirmed diagnosis of primary wAIHA or systemic lupus erythematosus (SLE)-associated wAIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations)
  • Participants who have previously failed to maintain a sustained response after treatment with corticosteroids.
  • Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.
  • Up-to-date vaccination status as per local guidelines.
  • Body mass index (BMI) >17.5 and <40 kg/m2
  • All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Part B only

  • Evidence of treatment efficacy to rilzabrutinib as defined by achieving overall response during Part A.
  • Completion of Part A treatment period (24 weeks).

Exclusion Criteria:

  • Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator.
  • Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.
  • Secondary wAIHA from any cause including drugs, lymphoproliferative disorders (low-count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed.
  • Myelodysplastic syndrome.
  • Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA.
  • HIV infection.
  • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to treatment start.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.

Part B only

  • Participants who receive any therapy during Part A known to be active in wAIHA.
  • Presence of unacceptable side effect(s) or toxicity associated with rilzabrutinib such that there is an unfavorable risk-benefit assessment for continued treatment with rilzabrutinib in the opinion of the Investigator and/or Sponsor.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • TOI Clinical Research LLC_ Cerritos_Investigational Site Number: 8400006Recruiting
  • TOI Clinical Research LLC_Glendale_Investigational Site Number: 8400006Recruiting
  • TOI Clinical Research LLC_Long Beach_Investigational Site Number: 8400006Recruiting
  • University of Southern California_Investigational Site Number: 8400009
  • TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006Recruiting
  • The Lundquist Institute_Investigational Site Number: 8400005Recruiting
  • TOI Clinical Research LLC_ Whittier_Investigational Site Number: 8400006Recruiting
  • Georgetown University Hospital_Investigational Site Number: 8400003Recruiting
  • Oncology & Hematology Associates of West Broward_Investigational Site Number: 8400002Recruiting
  • Massachusetts General Hospital_Investigational Site Number: 8400001Recruiting
  • Hanush-Krankenhaus_Investigational Site Number: 0400001Recruiting
  • Peking Union Medical College Hospital_Investigational Site Number: 1560002Recruiting
  • Institute of hematology&blood diseases hospital_Investigational Site Number: 1560003Recruiting
  • Odense Universitetshospital Hæmatologisk Forskningsenhed_Investigational Site Number: 2080001Recruiting
  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz_Investigational Site Number: 3480001
  • Ospedale Giuseppe Moscati_Investigational Site Number: 3800002Recruiting
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"_Investigational Site Number: 3800003Recruiting
  • Ospedale Maggiore Policlinico_Investigational Site Number: 3800001Recruiting
  • Hospital Universitario de Cruces_Investigational Site Number: 7240004Recruiting
  • Hospital Clinic de Barcelona_Investigational Site Number: 7240001Recruiting
  • Hospital Universitario La Paz_Investigational Site Number: 7240003Recruiting
  • Hospital Universitario Virgen del Rocío_Investigational Site Number: 7240002Recruiting
  • Leeds Teaching Hospitals NHS Trust_Investigational Site Number: 8260001Recruiting
  • Barts Health NHS Trust_Investigational Site Number: 8260005Recruiting
  • Imperial College Healthcare NHS Trust_Investigational Site Number: 8260002Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rilzabrutinib

Arm Description

Oral rilzabrutinib 400 mg BID

Outcomes

Primary Outcome Measures

Part A: Proportion of participants with overall hemoglobin response
Response is defined as an increase in hemoglobin (Hb) by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days, without biochemical resolution of hemolysis at the time response is achieved and an absence of rescue medications during the last 4 weeks. Complete Response is defined as hemoglobin ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, lactate dehydrogenase (LDH) , haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and an absence of rescue medications during the last 4 weeks.
Part B: Proportion of participants who maintain durable response achieved during Part A or achieve a durable response during Part B and have a hemoglobin response
Durable response (Part B) is defined as Hb level ≥10 g/dL with an increase from baseline (Part A) of ≥2 g/dL on three consecutive scheduled visits during Week 24 to Week 50; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.

Secondary Outcome Measures

Proportion of participants with durable hemoglobin response
Durable response (Part A) is defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the 24-week treatment period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.
Median time from baseline to first hemoglobin response
Frequency of rescue therapy (any wAIHA-directed therapy other than predniso[lo]ne or transfusion) received
Change from baseline in FACIT-Fatigue scale score
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale is a 13-item questionnaire used to assesses self-reported fatigue and its impact on daily activities and function.
Incidence of treatment emergent adverse events (TEAEs), serious TEAEs, adverse events of special interest (AESIs)
Safety assessment including clinical laboratory evaluations, vital sign measurements and ECG

Full Information

First Posted
August 5, 2021
Last Updated
July 26, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05002777
Brief Title
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
Official Title
A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This is a single group treatment, Phase 2, open-label, study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in adult patients with wAIHA. All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A. Participants who complete Part A and are deemed eligible for Part B will continue to receive the study medication for 52 weeks following the Last Patient In (LPI-Part B). There will be a 7-day safety follow-up period after receiving the last dose of study drug either in Part A (for those not eligible for Part B or early terminated) or Part B. The estimated total duration of the study is approximately 137 weeks (Parts A and B), including the follow-up period. For participants deemed ineligible for Part B, the total length of the study will be 29 weeks (Part A only), including screening and the follow-up period. In Part B, participants who temporarily stop rilzabrutinib treatment and maintain a durable response from W50 to W74, will have their EOS visit at Week 75. In this case, participation will be for 79 weeks including the screening period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warm Autoimmune Hemolytic Anemia (wAIHA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rilzabrutinib
Arm Type
Experimental
Arm Description
Oral rilzabrutinib 400 mg BID
Intervention Type
Drug
Intervention Name(s)
rilzabrutinib
Other Intervention Name(s)
PRN1008/SAR444671
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Primary Outcome Measure Information:
Title
Part A: Proportion of participants with overall hemoglobin response
Description
Response is defined as an increase in hemoglobin (Hb) by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days, without biochemical resolution of hemolysis at the time response is achieved and an absence of rescue medications during the last 4 weeks. Complete Response is defined as hemoglobin ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, lactate dehydrogenase (LDH) , haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and an absence of rescue medications during the last 4 weeks.
Time Frame
By Week 24 in Part A
Title
Part B: Proportion of participants who maintain durable response achieved during Part A or achieve a durable response during Part B and have a hemoglobin response
Description
Durable response (Part B) is defined as Hb level ≥10 g/dL with an increase from baseline (Part A) of ≥2 g/dL on three consecutive scheduled visits during Week 24 to Week 50; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.
Time Frame
At Week 50 in Part B
Secondary Outcome Measure Information:
Title
Proportion of participants with durable hemoglobin response
Description
Durable response (Part A) is defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the 24-week treatment period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.
Time Frame
By Week 24 in Part A
Title
Median time from baseline to first hemoglobin response
Time Frame
From Day 1 to Week 24 in Part A
Title
Frequency of rescue therapy (any wAIHA-directed therapy other than predniso[lo]ne or transfusion) received
Time Frame
After Week 1 of treatment to Week 24 in Part A and Week 75 in Part B
Title
Change from baseline in FACIT-Fatigue scale score
Description
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale is a 13-item questionnaire used to assesses self-reported fatigue and its impact on daily activities and function.
Time Frame
Until Week 24 in Part A and Week 75 in Part B
Title
Incidence of treatment emergent adverse events (TEAEs), serious TEAEs, adverse events of special interest (AESIs)
Description
Safety assessment including clinical laboratory evaluations, vital sign measurements and ECG
Time Frame
Until Week 24 in Part A and Week 75 in Part B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients with a confirmed diagnosis of primary wAIHA or systemic lupus erythematosus (SLE)-associated wAIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations) Participants who have previously failed to maintain a sustained response after treatment with corticosteroids. Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower. Up-to-date vaccination status as per local guidelines. Body mass index (BMI) >17.5 and <40 kg/m2 All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Part B only Evidence of treatment efficacy to rilzabrutinib as defined by achieving overall response during Part A. Completion of Part A treatment period (24 weeks). Exclusion Criteria: Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator. Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years. Secondary wAIHA from any cause including drugs, lymphoproliferative disorders (low-count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed. Myelodysplastic syndrome. Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA. HIV infection. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to treatment start. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. Part B only Participants who receive any therapy during Part A known to be active in wAIHA. Presence of unacceptable side effect(s) or toxicity associated with rilzabrutinib such that there is an unfavorable risk-benefit assessment for continued treatment with rilzabrutinib in the opinion of the Investigator and/or Sponsor. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
ext option 6
Email
Contact-US@sanofi.com
Facility Information:
Facility Name
TOI Clinical Research LLC_ Cerritos_Investigational Site Number: 8400006
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Phone
562-693-4477
Email
kirstenbettino@theoncologyinstitute.com
First Name & Middle Initial & Last Name & Degree
Arati Chand, Dr.
Facility Name
TOI Clinical Research LLC_Glendale_Investigational Site Number: 8400006
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Phone
562-693-4477
Email
kirstenbettino@theoncologyinstitute.com
First Name & Middle Initial & Last Name & Degree
Arati Chand, Dr.
Facility Name
TOI Clinical Research LLC_Long Beach_Investigational Site Number: 8400006
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Phone
562-693-4477
Email
kirstenbettino@theoncologyinstitute.com
First Name & Middle Initial & Last Name & Degree
Arati Chand, Dr
Facility Name
University of Southern California_Investigational Site Number: 8400009
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Duran
Phone
323-865-0371
Email
duran_c@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Howard Liebman
Facility Name
TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Phone
562-693-4477
Email
kirstenbettino@theoncologyinstitute.com
First Name & Middle Initial & Last Name & Degree
Arati Chand, Dr
Facility Name
The Lundquist Institute_Investigational Site Number: 8400005
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie La Barbera
Phone
310-618-9375
Email
katie.labarbera@lundquist.org
First Name & Middle Initial & Last Name & Degree
Sarah Tomassetti
Facility Name
TOI Clinical Research LLC_ Whittier_Investigational Site Number: 8400006
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Phone
562-693-4477
Email
kirstenbettino@theoncologyinstitute.com
First Name & Middle Initial & Last Name & Degree
Arati Chand, Dr
Facility Name
Georgetown University Hospital_Investigational Site Number: 8400003
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Steffen
Phone
202-687-0116
Email
js4936@georgetown.edu
First Name & Middle Initial & Last Name & Degree
Catherine Broome
Facility Name
Oncology & Hematology Associates of West Broward_Investigational Site Number: 8400002
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Conceicao
Phone
754-269-5990
Email
jconceicao@advancedresearchfl.com
First Name & Middle Initial & Last Name & Degree
Sumit Sawhney
Facility Name
Massachusetts General Hospital_Investigational Site Number: 8400001
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Chase
Phone
617-643-1821
Email
jkchase@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
David Kuter
Facility Name
Hanush-Krankenhaus_Investigational Site Number: 0400001
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barba Dixer
Phone
+43 1 91021-85435
Email
barbara.dixer@oegk.at
First Name & Middle Initial & Last Name & Degree
Michael Fillitz, Dr.
Facility Name
Peking Union Medical College Hospital_Investigational Site Number: 1560002
City
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Han, Dr.
Phone
13601059938
Email
hanbing_li@sina.com.cn
First Name & Middle Initial & Last Name & Degree
Bing Han, Dr.
Facility Name
Institute of hematology&blood diseases hospital_Investigational Site Number: 1560003
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhao, Dr
Email
zhaoxin@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Xin Zhao, Dr
Facility Name
Odense Universitetshospital Hæmatologisk Forskningsenhed_Investigational Site Number: 2080001
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Fredriksen, Dr
Facility Name
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz_Investigational Site Number: 3480001
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Batai Arpad
Phone
+36 20 970 9318
Email
labatai@mail.fmkorhaz.hu
First Name & Middle Initial & Last Name & Degree
Batai Arpad, Dr.
Facility Name
Ospedale Giuseppe Moscati_Investigational Site Number: 3800002
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Risitano, Prof
Email
amrisita@unina.it
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"_Investigational Site Number: 3800003
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Lucchesi, Dr
Email
alessandro.lucchesi@irst.emr.it
Facility Name
Ospedale Maggiore Policlinico_Investigational Site Number: 3800001
City
Milan
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilma Barcellini, Prof
Email
wilma.barcellini@policlinico.mi.it
Facility Name
Hospital Universitario de Cruces_Investigational Site Number: 7240004
City
Barakaldo
ZIP/Postal Code
48093
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Vara, Dr.
Phone
0034946006000
Email
miriam.varapampliega@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Rafael del Orbe, Dr.
Facility Name
Hospital Clinic de Barcelona_Investigational Site Number: 7240001
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Cid, Dr
Phone
0034932275400
Email
jcid@clinic.cat
First Name & Middle Initial & Last Name & Degree
Joan Cid, Dr.
Facility Name
Hospital Universitario La Paz_Investigational Site Number: 7240003
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Marta Morado
Phone
0034917277000
Email
marta.morado@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Marta Morado
Facility Name
Hospital Universitario Virgen del Rocío_Investigational Site Number: 7240002
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Maria Eva Mingot
Phone
0034955012000
Email
memingot@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Maria Eva Mingot
Facility Name
Leeds Teaching Hospitals NHS Trust_Investigational Site Number: 8260001
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
0113 20(67624)
First Name & Middle Initial & Last Name & Degree
Quentin Hill, Dr
Facility Name
Barts Health NHS Trust_Investigational Site Number: 8260005
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick Chen, Dr
Phone
020 3246 0335
Email
frederick.chen1@nhs.net
First Name & Middle Initial & Last Name & Degree
Frederick Chen, Dr
Facility Name
Imperial College Healthcare NHS Trust_Investigational Site Number: 8260002
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Cooper, Dr
Phone
020 331 31195
Email
nichola.cooper1@nhs.net
First Name & Middle Initial & Last Name & Degree
Nicola Cooper, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

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