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| ID | Type | Description | Link |
|---|---|---|---|
| C5361002 | Other Identifier | Alias Study Number | |
| 2020-005287-60 | EudraCT Number | CTIS (EU) | |
| 2020-005287-60 | Registry Identifier | CTIS (EU) |
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Study was terminated due to poor accrual and associated recrutiment challenges
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This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.
The study will include approximately 280 adult and adolescent participants (≥ 12 years of age) with SCD.
Eligible participants will be administered inclacumab or placebo intravenous (IV) as a single dose.
Participants that complete the study through Day 90 will be provided the opportunity to enroll in an open-label extension (OLE) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inclacumab 30 mg/kg | Experimental | Inclacumab 30 mg/kg administered intravenously (IV) |
|
| placebo | Placebo Comparator | Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclacumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization | A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. | Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization | A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. Time to first VOC that required admission to a healthcare facility and treatment with parenteral pain medication within 90 days was defined as the time between randomization date and onset date of first VOC event. For participants who did not experience a protocol-defined VOC within 90 days of randomization, time to first VOC was censored at the end of their time at risk (participant's end of study date or Study Day 91, whichever was earlier). An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. Kaplan-Meier method used for analysis. |
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Inclusion Criteria:
Participant has an index VOC. The index VOC is any VOC that required admission to a healthcare facility and treatment with parenteral pain medication. An admission for the index VOC includes:
for an acute episode of pain with no other cause other than a vaso- occlusive event that includes the following:
Participant has a confirmed diagnosis of SCD (any genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing at Baseline.
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 Screening as determined by documented medical history. The index VOC is not to be considered as one of the 2 to 10 events. A prior VOC is defined as an acute episode of pain that:
Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to Screening 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 Screening and expected to continue with the stabilized regimen throughout the course of the study.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strada Patient Care Center | Mobile | Alabama | 36604 | United States | ||
| University of South Alabama Children's and Women's Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 72 participants were enrolled and randomized in the study.
In this study, participants with sickle cell disease (SCD), aged greater than or equal to (>=) 12 years were randomized to receive either inclacumab or placebo for reducing the frequency of re-admissions due to vaso-occlusive crisis (VOC) after an index VOC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inclacumab 30 mg/kg | Participants were administered with inclacumab 30 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1 as a single dose. |
| FG001 | Placebo | Participants were administered with placebo IV infusion on Day 1 as a single dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2021 | Nov 20, 2024 |
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Double blind study
| Placebo | Drug | 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. |
|
| Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) or censored day, whichever occurred earlier |
| Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 30 Days of Randomization | A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. | Within 30 days of randomization (randomization happened on Day 1 [Day 1 to Day 31]) |
| Rate of VOCs Leading to a Healthcare Visit That Requires Parenteral Pain Medication or an Increase in Treatment With Oral Narcotics Within 90 Days Following Randomization | VOC leading to a healthcare visit was defined as VOC at (hospital, emergency room, clinic visit, or remote contact with a healthcare provider) that required parenteral pain medication (e.g., parenteral narcotic agents or parenteral nonsteroidal anti-inflammatory drugs [NSAIDs]), or an increased treatment with oral narcotics. Complicated VOCs included acute chest syndrome (ACS),hepatic sequestration, splenic sequestration, and priapism. For each participant, the time period at risk for evaluation of VOCs was from date of randomization to the participant's end of study date or study Day 91, whichever was earlier. In this outcome measure adjusted rates of VOCs (percentages) reported were based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea use (yes, no). All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. | Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) |
| Mobile |
| Alabama |
| 36604 |
| United States |
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| UCSF Benioff Children's Hospital, Oakland | Oakland | California | 94609 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| University of Michigan Hospitals - Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
| Functional Fluidics, Inc. | Detroit | Michigan | 48202 | United States |
| Alliance for Childhood Diseases dba Cure 4 The Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| DUMC Investigational Drug Services Pharmacy | Durham | North Carolina | 27710 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PPD Bioanalytical | Richmond | Virginia | 23230 | United States |
| Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Multihemo Servicos Medicos S/A | Recife | Pernambuco | 50070-460 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Casa de Saude Santa Marcelina | São Paulo | São Paulo | 08270-070 | Brazil |
| Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO | Rio de Janeiro | 20211-030 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP | São Paulo | 05403-000 | Brazil |
| CEPEC-Centro de Pesquisa Clinica | São Paulo | 08270-120 | Brazil |
| Clinica de la Costa Ltda. | Barranquilla | Atlántico | 080020 | Colombia |
| Organizacion Clinica Bonnadona Prevenir S.A.S. | Barranquilla | Atlántico | 080020 | Colombia |
| Hopital Avicenne | Bobigny | 93000 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Universitatsklinikum Regensburg Padiatrische Hamatologie, Onkologie und Stammzelltransplantation | Regensburg | 93053 | Germany |
| Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera | Genova | Genoa | 16128 | Italy |
| S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro | Genova | 16128 | Italy |
| DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitell | Naples | 80138 | Italy |
| UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria | Naples | 80138 | Italy |
| UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli" | Naples | 80138 | Italy |
| UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli" | Naples | 80138 | Italy |
| Kemri/Crdr, Siaya, Kemri Clinical Research Annex, | Kisumu | Siaya County | 40600 | Kenya |
| International Cancer Institute | Eldoret | 30100 | Kenya |
| Kenya medical Research Institute-centre for Respiratory Disease Research | Nairobi | 00100 | Kenya |
| Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES) | Nairobi | 00200 | Kenya |
| American University of Beirut Medical Center | Hamra | Beirut | Lebanon |
| Nini Hospital | Tripoli | North Lebanon | Lebanon |
| University of Calabar Teaching Hospital | Calabar | Cross River State | 540242 | Nigeria |
| National Hospital Abuja | Abuja | Federal Capital Territory | 900211 | Nigeria |
| University of Abuja Teaching Hospital | Gwagwalada | Federal Capital Territory | 902101 | Nigeria |
| Ahmadu Bello University Teaching Hospital (ABUTH) | Zaria | Kaduna State | 810107 | Nigeria |
| University of Nigeria Teaching Hospital | Enugu | 460000 | Nigeria |
| Barau Dikko Teaching Hospital/Kaduna State University | Kaduna | 800212 | Nigeria |
| Aminu Kano Teaching Hospital | Kano | 700223 | Nigeria |
| Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital | Lagos | 100254 | Nigeria |
| Sultan Qaboos University Hospital | Muscat | 123 | Oman |
| Prince Mohammed bin Nasser Hospital | Jizan | Southern | 82943 | Saudi Arabia |
| Hacettepe University | Ankara | Altindag/sihhiye | 06230 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi | Yenischir, Mersin | Mersin | 33343 | Turkey (Türkiye) |
| Baskent University Hospital | Adana | Yuregir | 01250 | Turkey (Türkiye) |
| Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji | Adana | 01130 | Turkey (Türkiye) |
| Guy's & Thomas' NHS Foundation Trust | London | England | SE1 9RT | United Kingdom |
| Matero Clinical Research Site, | Lusaka | 10101 | Zambia |
| University Teaching Hospital- Children's Hospital | Lusaka | 10101 | Zambia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inclacumab 30 mg/kg | Participants were administered with inclacumab 30 mg/kg IV infusion on Day 1 as a single dose. |
| BG001 | Placebo | Participants were administered with placebo IV infusion on Day 1 as a single dose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization | A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. | The intent-to-treat (ITT) population included all randomized participants. Participants without an observed VOC who discontinued the study prior to Day 91 were assumed to have experienced at least one VOC. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization | A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. Time to first VOC that required admission to a healthcare facility and treatment with parenteral pain medication within 90 days was defined as the time between randomization date and onset date of first VOC event. For participants who did not experience a protocol-defined VOC within 90 days of randomization, time to first VOC was censored at the end of their time at risk (participant's end of study date or Study Day 91, whichever was earlier). An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. Kaplan-Meier method used for analysis. | The ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | Days | Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) or censored day, whichever occurred earlier |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 30 Days of Randomization | A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. | The ITT population included all randomized participants. Participants without an observed VOC who discontinued the study prior to Day 31 were assumed to have experienced at least one VOC. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days of randomization (randomization happened on Day 1 [Day 1 to Day 31]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of VOCs Leading to a Healthcare Visit That Requires Parenteral Pain Medication or an Increase in Treatment With Oral Narcotics Within 90 Days Following Randomization | VOC leading to a healthcare visit was defined as VOC at (hospital, emergency room, clinic visit, or remote contact with a healthcare provider) that required parenteral pain medication (e.g., parenteral narcotic agents or parenteral nonsteroidal anti-inflammatory drugs [NSAIDs]), or an increased treatment with oral narcotics. Complicated VOCs included acute chest syndrome (ACS),hepatic sequestration, splenic sequestration, and priapism. For each participant, the time period at risk for evaluation of VOCs was from date of randomization to the participant's end of study date or study Day 91, whichever was earlier. In this outcome measure adjusted rates of VOCs (percentages) reported were based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea use (yes, no). All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of VOCs | Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) |
|
Day 1 through Day 161
Safety population included randomized participants who received treatment with study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inclacumab 30 mg/kg | Participants were administered with inclacumab 30 mg/kg IV infusion on Day 1 as a single dose. | 1 | 36 | 4 | 36 | 20 | 36 |
| EG001 | Placebo | Participants were administered with placebo IV infusion on Day 1 as a single dose. | 0 | 33 | 1 | 33 | 11 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Sexually transmitted disease | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2023 | Nov 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000098644 | Vaso-Occlusive Crises |
| D006402 | Hematologic Diseases |
| D012805 | Sickle Cell Trait |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604431 | inclacumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
Participants were administered with placebo IV infusion on Day 1 as a single dose.
|
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Participants were administered with placebo IV infusion on Day 1 as a single dose. |
|
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