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A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inclacumab
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, RBCs, sickle-like shape, mutation in hemoglobin gene, Sickle Cell Disease, SCD, Vaso-occlusive Crisis, VOC, SCA, Open Label

Eligibility Criteria

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

Inclusion Criteria:

Participants who meet all the following criteria will be eligible for study enrollment:

  1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
  2. Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
  3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.

    Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study.

  4. If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
  5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:

  1. Female participant who is breastfeeding or pregnant.
  2. Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
  3. Participant withdrew consent from the originating inclacumab clinical study.
  4. Participant was lost to follow-up from the originating inclacumab clinical study.
  5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.

Sites / Locations

  • Strada Patient Care Center, Pediatric HematologyRecruiting
  • University of South Alabama Children's and Women's HospitalRecruiting
  • Arkansas Children's HospitalRecruiting
  • Children's Hospital and Research Center at OaklandRecruiting
  • UC Irvine Medical CenterRecruiting
  • University of South Florida, Department of PediatricsRecruiting
  • USF Health South Tampa Center for Advanced Healthcare (STC)Recruiting
  • St. Joseph's HospitalRecruiting
  • John S Curran,MD, Children's Health Center/Children's Medical Center (CMS)Recruiting
  • USF Health Carol and Frank Morsani Center for Advanced HealthcareRecruiting
  • University of Illinois at ChicagoRecruiting
  • University of Illinois Hospital and Health SystemsRecruiting
  • Brigham And Woman's HospitalRecruiting
  • Dana-Farber Cancer Institute IDS PharmacyRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of Michigan Hospitals - Michigan MedicineRecruiting
  • Jacobi Medical CenterRecruiting
  • Erie Country Medical CenterRecruiting
  • Duke University Medical CenterRecruiting
  • DUMC Investigational Drug Services PharmacyRecruiting
  • Instituto D'Or de Pesquisa e Ensino - Hospital São RafaelRecruiting
  • Hemocentro de Belo Horizonte - Fundacao HemominasRecruiting
  • Hospital das Clinicas da Universidade Federal de Minas GeraisRecruiting
  • Multihemo Servicos Medicos S/ARecruiting
  • Hospital de Clínicas de Porto AlegreRecruiting
  • Fundação Faculdade Regional de Medicina de São José do Rio PretoRecruiting
  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USPRecruiting
  • Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIORecruiting
  • Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.ARecruiting
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSPRecruiting
  • Clinica de la Costa Ltda.Recruiting
  • Sociedad de Oncología y hematología del CesarRecruiting
  • Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und StammzelltransplantationRecruiting
  • Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali GallieraRecruiting
  • S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferroRecruiting
  • DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi VanvitelRecruiting
  • UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale
  • UO di Farmacia Clinica,Dipartimento di Medicina SperimentaleRecruiting
  • UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Recruiting
  • UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Recruiting
  • 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 Clinical Research AnnexRecruiting
  • International Cancer InstituteRecruiting
  • Kenya Medical Research Institute - Centre for Respiratory Disease ResearchRecruiting
  • Strathmore University CREATESRecruiting
  • American University of Beirut Medical CenterRecruiting
  • Nini HospitalRecruiting
  • University of Calabar Teaching Hospital
  • National Hospital AbujaRecruiting
  • University of Abuja Teaching Hospital
  • Ahmadu Bello University Teaching Hospital
  • Aminu Kano Teaching Hospital
  • Department of Pediatrics, College of Medicine, Lagos University Teaching HospitalRecruiting
  • Sultan Qaboos University HospitalRecruiting
  • Prince Mohammed bin Nasser HospitalRecruiting
  • NIMR-Mbeya Medical Research CenterRecruiting
  • Acibadem Adana Hastanesi Cocuk Hematoloji OnkolojiRecruiting
  • Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital HematologyRecruiting
  • Hacettepe University Ihsan Dogramaci Children HospitalRecruiting
  • Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi HastanesiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inclacumab 30 mg/kg

Arm Description

Inclacumab 30 mg/kg administered intravenously (IV)

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs).

Secondary Outcome Measures

Annualized rate of VOCs
Annualized rate of VOCs that require admission to a healthcare facility and treatment.
Annualized number of days of inpatient hospitalization for a VOC.
Annualized rate of all SCD-related urgent care visits to the clinic, emergency room, and hospital.
Proportion of total days missed from school or work due to SCD pain symptoms for the first 48 weeks.
Annualized rate of complicated VOCs.
Annualized rate of RBC transfusions.

Full Information

First Posted
March 29, 2022
Last Updated
September 26, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05348915
Brief Title
A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
Official Title
An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
November 15, 2028 (Anticipated)
Study Completion Date
November 15, 2028 (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 study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.
Detailed Description
The study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with SCD. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inclacumab 30 mg/kg
Arm Type
Experimental
Arm Description
Inclacumab 30 mg/kg administered intravenously (IV)
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.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs).
Time Frame
Day 1 through study completion, an estimate of 5 years
Secondary Outcome Measure Information:
Title
Annualized rate of VOCs
Time Frame
Day 1 through study completion, an estimate of 5 years
Title
Annualized rate of VOCs that require admission to a healthcare facility and treatment.
Time Frame
Day 1 through study completion, an estimate of 5 years
Title
Annualized number of days of inpatient hospitalization for a VOC.
Time Frame
Day 1 through study completion, an estimate of 5 years
Title
Annualized rate of all SCD-related urgent care visits to the clinic, emergency room, and hospital.
Time Frame
Day 1 through study completion, an estimate of 5 years
Title
Proportion of total days missed from school or work due to SCD pain symptoms for the first 48 weeks.
Time Frame
Day 1 through study completion, an estimate of 5 years
Title
Annualized rate of complicated VOCs.
Time Frame
Day 1 through study completion, an estimate of 5 years
Title
Annualized rate of RBC transfusions.
Time Frame
Day 1 through study completion, an estimate of 5 years
Other Pre-specified Outcome Measures:
Title
Plasma pharmacokinetic (PK) of inclacumab as assessed by population PK analysis using nonlinear mixed-effects modeling.
Description
Inclacumab concentrations will be measured from plasma samples. Population PK analysis using nonlinear mixed effects modeling will be performed to characterize inclacumab PK in plasma.
Time Frame
Day 1 through Week 48
Title
Incidence of anti-drug antibodies (ADA) to inclacumab.
Time Frame
Day 1 through Week 48
Title
PD parameter (P-selectin inhibition)
Time Frame
Day 1 through Week 48
Title
PD parameter (Platelet Leukocyte Aggregation)
Time Frame
Day 1 through Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who meet all the following criteria will be eligible for study enrollment: Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study. Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study. If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement. Exclusion Criteria: Participants meeting any of the following exclusion criteria will not be eligible for study enrollment: Female participant who is breastfeeding or pregnant. Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study. Participant withdrew consent from the originating inclacumab clinical study. Participant was lost to follow-up from the originating inclacumab clinical study. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
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
Strada Patient Care Center, Pediatric Hematology
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Alabama Children's and Women's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida, Department of Pediatrics
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
USF Health South Tampa Center for Advanced Healthcare (STC)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
John S Curran,MD, Children's Health Center/Children's Medical Center (CMS)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
USF Health Carol and Frank Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Illinois Hospital and Health Systems
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham And Woman's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute IDS Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Hospitals - Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Erie Country Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
DUMC Investigational Drug Services Pharmacy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hemocentro de Belo Horizonte - Fundacao Hemominas
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30130-110
Country
Brazil
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
Facility Name
Multihemo Servicos Medicos S/A
City
Recife
State/Province
PE
ZIP/Postal Code
50070-460
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
Facility Name
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
City
São Paulo
ZIP/Postal Code
01232-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica de la Costa Ltda.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Sociedad de Oncología y hematología del Cesar
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
City
Genova
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Recruiting
Facility Name
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
City
Genova
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Recruiting
Facility Name
DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitel
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Farmacia Azienda Ospedale Universita Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O.C. Farmacia Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
KEMRI/CRDR Siaya Clinical Research Annex
City
Kisumu
State/Province
Siaya
ZIP/Postal Code
40600
Country
Kenya
Individual Site Status
Recruiting
Facility Name
International Cancer Institute
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Kenya Medical Research Institute - Centre for Respiratory Disease Research
City
Nairobi
ZIP/Postal Code
00100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
Strathmore University CREATES
City
Nairobi
ZIP/Postal Code
00200
Country
Kenya
Individual Site Status
Recruiting
Facility Name
American University of Beirut Medical Center
City
Hamra
State/Province
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Nini Hospital
City
Tripoli
State/Province
North Lebanon
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
University of Calabar Teaching Hospital
City
Calabar
State/Province
Cross River State
ZIP/Postal Code
540242
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Name
National Hospital Abuja
City
Abuja
State/Province
FCT
ZIP/Postal Code
900211
Country
Nigeria
Individual Site Status
Recruiting
Facility Name
University of Abuja Teaching Hospital
City
Gwagwalada
State/Province
FCT
ZIP/Postal Code
902101
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Name
Ahmadu Bello University Teaching Hospital
City
Zaria
State/Province
Kaduna
ZIP/Postal Code
810107
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Name
Aminu Kano Teaching Hospital
City
Kano
ZIP/Postal Code
700223
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
City
Lagos
ZIP/Postal Code
100254
Country
Nigeria
Individual Site Status
Recruiting
Facility Name
Sultan Qaboos University Hospital
City
Muscat
ZIP/Postal Code
123
Country
Oman
Individual Site Status
Recruiting
Facility Name
Prince Mohammed bin Nasser Hospital
City
Jizan
State/Province
Southern
ZIP/Postal Code
82943
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
NIMR-Mbeya Medical Research Center
City
Mbeya
Country
Tanzania
Individual Site Status
Recruiting
Facility Name
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital Hematology
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Ihsan Dogramaci Children Hospital
City
Ankara
ZIP/Postal Code
06430
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Individual Site Status
Recruiting

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=GBT2104-133
Description
To obtain contact information for a study center near you, click here.
URL
http://www.gbt.com
Description
Global Blood Therapeutics (GBT) Website

Learn more about this trial

A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

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