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A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Primary Purpose

Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inclacumab
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring blood disorders, hemoglobin, red blood cells, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, Sickle Cell Disease, SCD, Vaso-occlusive Crises, VOC, SCA, RBCs

Eligibility Criteria

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

Inclusion Criteria:

  1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).

    Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.

  2. Participant is male or female, ≥ 12 years of age at the time of informed consent.

  3. Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which:

    • Has no medically determined cause other than a vaso-occlusive event, and
    • Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
    • Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
  4. Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
  5. Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.

Exclusion Criteria:

  1. Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
  2. Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
  3. Participant weighs > 133 kg (292 lbs.).

Other protocol-defined Inclusion/Exclusion may apply.

Sites / Locations

  • University of South Alabama Children's and Women's Hospital
  • University of South Alabama Mitchell Cancer Institute
  • University of South Alabama Strada Patient Care Center
  • Phoenix Children's Hospital
  • Arkansas Children's Hospital
  • UCSF Benioff Children's Hospital, Oakland
  • UC Irvine Health
  • Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell
  • University of South Florida
  • USF Health South Tampa Center for Advanced Healthcare
  • John S. Curran, MD.,Children's Health Center
  • USF Clinical Investigational Research Pharmacy
  • USF Health Carol & Frank Morsani Center for Advanced Healthcare
  • Children's Healthcare of Atlanta - Egleston
  • Children's Healthcare of Atlanta - Scottish Rite
  • Children's Healthcare of Atlanta
  • Hospital Pharmacy Services- Investigational Drug Services
  • Rush University Medical Center Investigator Pharmacy
  • Rush University Medical Center
  • University of Illinois Clinical Research Center (CRC)
  • University of Illinois Hospital and Health Sciences System(UI Health)
  • Dana-Farber Cancer Institute IDS Pharmacy
  • Dana-Farber Cancer Institute
  • University of Michigan Hospitals - Michigan Medicine
  • Jacobi Medical Center
  • Erie County Medical Center
  • Duke University Medical Center
  • DUMC Investigational Drug Services Pharmacy
  • St. Jude Children's Research Hospital
  • UT Physicians Comprehensive Sickle Cell Clinic
  • McGovern Medical School/Health Science Center Houston
  • Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
  • Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
  • Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
  • Hospital das Clinicas da Universidade Federal de Minas Gerais
  • Hemocentro de Belo Horizonte - Fundacao Hemominas
  • Hospital das Clinicas da Universidade Federal de Minas Gerais
  • Multihemo Serviços Médicos S/A
  • Hospital de Clínicas de Porto Alegre
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • Comite de Etica em Pesquisa - CEP do Hospital Alemao Oswaldo Cruz/ SP
  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
  • Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
  • Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP
  • Casa de Saúde Santa Marcelina
  • CEPEC-Centro de Pesquisa Clinica
  • Clinica de la Costa Ltda.
  • Organizacion Clinica Bonnadona Prevenir S.A.S.
  • Sociedad de Oncologia y hematologia del Cesar S.A.S.
  • Zagazig University Hospital
  • Al Kasr Al Ainy Cairo University Hospital
  • Cairo University Paediatric Hospital - abou el Reesh University Hospital
  • Faculty of Medicine Cairo University
  • AinShams University Hospital
  • Hôpital Avicenne
  • Hôpital Henri Mondor
  • Institut Universitaire du Cancer de Toulouse-Oncopole
  • Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
  • Sickle-Cell Office, Directorate of Child Health, Komfo Anokye Teaching Hospital
  • Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
  • S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro Azienda
  • DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria
  • DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitel
  • UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria
  • UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
  • UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
  • Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
  • Farmacia Azienda Ospedale Universita Padova
  • U.O.C. Farmacia Istituto Oncologico Veneto
  • KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
  • International Cancer Institute
  • Gertrude's Children Hospital
  • Kenya Medical Research Institute- Center for Respiratory Disease Research
  • Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
  • American University of Beirut Medical Center
  • Nini Hospital
  • University of Calabar Teaching Hospital
  • National Hospital Abuja
  • University of Abuja Teaching Hospital
  • Ahmadu Bello University Teaching Hospital
  • University of Nigeria Teaching Hospital
  • Barau Dikko Teaching Hospital/Kaduna State University
  • Aminu Kano Teaching Hospital
  • Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
  • Sultan َQaboos University Hospital
  • Prince Mohammed bin Nasser Hospital
  • NIMR-Mbeya Medical Research Center
  • Hacettepe University
  • Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
  • Baskent University Hospital
  • Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
  • Guy's and St Thomas' NHS Foundation Trust
  • King's College Hospital NHS Foundation Trust
  • Arthur Davison Childrens's Hospital
  • Matero Clinical Research Site,
  • University Teaching Hospital- Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

inclacumab, 30 mg/kg

placebo

Arm Description

Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks

Participants will receive placebo administered IV every 12 weeks.

Outcomes

Primary Outcome Measures

Rate of VOCs during the 48-week treatment period.
A VOC is defined as an acute episode of pain that: has no medically determined cause other than a vaso-occlusive event, and results in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or results in a remote contact with a healthcare provider; and requires parenteral narcotic agents, parenteral non-steroidal anti-inflammatoroy drugs (NSAIDS), or an increase in treatment with oral narcotics. Complicated VOCs of acute chest syndrome (ACS), hepatic sequestration, splenic sequestration, and priapism that meet the requirements listed above will be included in the primary endpoint

Secondary Outcome Measures

Time to first VOC during the 48-week treatment period.
Time to second VOC during the 48-week treatment period Efficacy.
Proportion of participants with no VOCs during the 48-week treatment period.
Rate of VOCs that required admission to a healthcare facility and treatment with parenteral pain medication during the 48-week treatment period.
Admission includes: (a) A hospital admission, or (b) An admission to an emergency room, observation unit, or infusion center for ≥ 12 hours, or (c) 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period.
Number of days of inpatient hospitalization for a VOC during the 48-week treatment period.
Incidence of treatment-emergent adverse events (TEAEs).

Full Information

First Posted
May 26, 2021
Last Updated
September 22, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04935879
Brief Title
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

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

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 Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Detailed Description
Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks. The total duration of treatment for each participant will be 48 weeks. Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
Keywords
blood disorders, hemoglobin, red blood cells, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, Sickle Cell Disease, SCD, Vaso-occlusive Crises, VOC, SCA, RBCs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind study
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inclacumab, 30 mg/kg
Arm Type
Experimental
Arm Description
Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo administered IV every 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Inclacumab
Intervention Description
Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug
Primary Outcome Measure Information:
Title
Rate of VOCs during the 48-week treatment period.
Description
A VOC is defined as an acute episode of pain that: has no medically determined cause other than a vaso-occlusive event, and results in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or results in a remote contact with a healthcare provider; and requires parenteral narcotic agents, parenteral non-steroidal anti-inflammatoroy drugs (NSAIDS), or an increase in treatment with oral narcotics. Complicated VOCs of acute chest syndrome (ACS), hepatic sequestration, splenic sequestration, and priapism that meet the requirements listed above will be included in the primary endpoint
Time Frame
Day 1- Week 48
Secondary Outcome Measure Information:
Title
Time to first VOC during the 48-week treatment period.
Time Frame
Day 1- Week 48
Title
Time to second VOC during the 48-week treatment period Efficacy.
Time Frame
Day 1- Week 48
Title
Proportion of participants with no VOCs during the 48-week treatment period.
Time Frame
Day 1- Week 48
Title
Rate of VOCs that required admission to a healthcare facility and treatment with parenteral pain medication during the 48-week treatment period.
Description
Admission includes: (a) A hospital admission, or (b) An admission to an emergency room, observation unit, or infusion center for ≥ 12 hours, or (c) 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period.
Time Frame
Day 1- Week 48
Title
Number of days of inpatient hospitalization for a VOC during the 48-week treatment period.
Time Frame
Day 1- Week 48
Title
Incidence of treatment-emergent adverse events (TEAEs).
Time Frame
Day 1- Week 48
Other Pre-specified Outcome Measures:
Title
PD parameter (P-selectin inhibition)
Description
To characterize the pharmacodynamics (PD) (P-selectin inhibition) of inclacumab at 30 mg/kg
Time Frame
Day 1- Week 48
Title
PD parameter (Platelet Leukocyte Aggregation)
Description
To characterize the pharmacodynamics (PD) (PLA) of inclacumab at 30 mg/kg
Time Frame
Day 1- Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening. Participant is male or female, ≥ 12 years of age at the time of informed consent. Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which: Has no medically determined cause other than a vaso-occlusive event, and Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study. Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study. Exclusion Criteria: Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion). Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit Participant weighs > 133 kg (292 lbs.). Other protocol-defined Inclusion/Exclusion may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Children's and Women's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
University of South Alabama Strada Patient Care Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UCSF Benioff Children's Hospital, Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1163
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
USF Health South Tampa Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
John S. Curran, MD.,Children's Health Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
USF Clinical Investigational Research Pharmacy
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
USF Health Carol & Frank Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Healthcare of Atlanta - Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Hospital Pharmacy Services- Investigational Drug Services
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-4333
Country
United States
Facility Name
Rush University Medical Center Investigator Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois Clinical Research Center (CRC)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois Hospital and Health Sciences System(UI Health)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Dana-Farber Cancer Institute IDS Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Hospitals - Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
DUMC Investigational Drug Services Pharmacy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
UT Physicians Comprehensive Sickle Cell Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
McGovern Medical School/Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Hospital das Clinicas da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Hemocentro de Belo Horizonte - Fundacao Hemominas
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30130-110
Country
Brazil
Facility Name
Hospital das Clinicas da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Multihemo Serviços Médicos S/A
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-460
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SAO Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Comite de Etica em Pesquisa - CEP do Hospital Alemao Oswaldo Cruz/ SP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-903
Country
Brazil
Facility Name
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
City
Ribeirão Preto
State/Province
SÃO Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
City
São Paulo
ZIP/Postal Code
01232-010
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Casa de Saúde Santa Marcelina
City
São Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
CEPEC-Centro de Pesquisa Clinica
City
São Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Facility Name
Clinica de la Costa Ltda.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Organizacion Clinica Bonnadona Prevenir S.A.S.
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Sociedad de Oncologia y hematologia del Cesar S.A.S.
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Zagazig University Hospital
City
Zagazig
State/Province
ASH Sharqia
ZIP/Postal Code
44519
Country
Egypt
Facility Name
Al Kasr Al Ainy Cairo University Hospital
City
Elmanial
State/Province
Cairo Governorate
ZIP/Postal Code
11562
Country
Egypt
Facility Name
Cairo University Paediatric Hospital - abou el Reesh University Hospital
City
El-Rashidy Street, ElSayeda Zeinb
State/Province
Cairo
ZIP/Postal Code
11617
Country
Egypt
Facility Name
Faculty of Medicine Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Name
AinShams University Hospital
City
Cairo
ZIP/Postal Code
11588
Country
Egypt
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Institut Universitaire du Cancer de Toulouse-Oncopole
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Sickle-Cell Office, Directorate of Child Health, Komfo Anokye Teaching Hospital
City
Kumasi
State/Province
Ashanti
Country
Ghana
Facility Name
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro Azienda
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitel
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Farmacia Azienda Ospedale Universita Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
U.O.C. Farmacia Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
City
Kisumu
State/Province
Siaya
ZIP/Postal Code
40600
Country
Kenya
Facility Name
International Cancer Institute
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
Gertrude's Children Hospital
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Facility Name
Kenya Medical Research Institute- Center for Respiratory Disease Research
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Facility Name
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
City
Nairobi
ZIP/Postal Code
00200
Country
Kenya
Facility Name
American University of Beirut Medical Center
City
Hamra
State/Province
Beirut
Country
Lebanon
Facility Name
Nini Hospital
City
Tripoli
State/Province
North Lebanon
Country
Lebanon
Facility Name
University of Calabar Teaching Hospital
City
Calabar
State/Province
Cross River State
ZIP/Postal Code
540242
Country
Nigeria
Facility Name
National Hospital Abuja
City
Abuja
State/Province
FCT
ZIP/Postal Code
900211
Country
Nigeria
Facility Name
University of Abuja Teaching Hospital
City
Gwagwalada
State/Province
FCT
ZIP/Postal Code
902101
Country
Nigeria
Facility Name
Ahmadu Bello University Teaching Hospital
City
Zaria
State/Province
Kaduna
ZIP/Postal Code
1100011
Country
Nigeria
Facility Name
University of Nigeria Teaching Hospital
City
Enugu
ZIP/Postal Code
460000
Country
Nigeria
Facility Name
Barau Dikko Teaching Hospital/Kaduna State University
City
Kaduna
ZIP/Postal Code
800212
Country
Nigeria
Facility Name
Aminu Kano Teaching Hospital
City
Kano
ZIP/Postal Code
700233
Country
Nigeria
Facility Name
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
City
Lagos
ZIP/Postal Code
100254
Country
Nigeria
Facility Name
Sultan َQaboos University Hospital
City
Muscat
ZIP/Postal Code
123
Country
Oman
Facility Name
Prince Mohammed bin Nasser Hospital
City
Jizan
State/Province
Southern
ZIP/Postal Code
82943
Country
Saudi Arabia
Facility Name
NIMR-Mbeya Medical Research Center
City
Mbeya
Country
Tanzania
Facility Name
Hacettepe University
City
Ankara
State/Province
Altindag/sihhiye
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
City
Yenisehir
State/Province
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Baskent University Hospital
City
Adana
State/Province
Yuregir
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
State/Province
London CITY OF
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
London CITY OF
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Arthur Davison Childrens's Hospital
City
Ndola
State/Province
Copperbelt
ZIP/Postal Code
10101
Country
Zambia
Facility Name
Matero Clinical Research Site,
City
Lusaka
ZIP/Postal Code
10101
Country
Zambia
Facility Name
University Teaching Hospital- Children's Hospital
City
Lusaka
ZIP/Postal Code
10101
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=GBT2104-131
Description
To obtain contact information for a study center near you, click here.
URL
https://www.gbt.com/
Description
Global Blood Therapeutics (GBT) website

Learn more about this trial

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

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