Sickle Cell DiseasePhase 3NCT04927247
A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
A Phase 3 study testing Inclacumab in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Pfizer at 59 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease
- What is being tested?
- Inclacumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 59 sitesin 14 countries
- Study dates
- 9 Dec 2021to 24 Nov 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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
- for an acute episode of pain with no other cause other than a vaso- occlusive event that includes the following:
- Uncomplicated VOC,
Show all 18Show fewer
- Acute chest syndrome (ACS),
- Acute hepatic sequestration,
- Acute splenic sequestration, or
- Priapism.
- 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:
- Has no medically determined cause other than a vaso-occlusive event, and
- Results in a visit to a healthcare 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 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.
Who cannot join
- 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 Screening.
- Participant weighs > 133 kg (292 lbs.).
- Other protocol-defined Inclusion/Exclusion may apply.
Trial locations and contacts
59 sites in 14 countries.
59 sites in 14 countries
United States17 sites
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan, 48109
Erie County Medical Center
Buffalo, New York, 14215
Functional Fluidics, Inc.
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27705
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina, 27710
Alliance for Childhood Diseases dba Cure 4 The Kids Foundation
Las Vegas, Nevada, 89135
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Strada Patient Care Center
Mobile, Alabama, 36604
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, 36604
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604
UCSF Benioff Children's Hospital, Oakland
Oakland, California, 94609
Children's Hospital of Orange County
Orange, California, 92868
Phoenix Children's Hospital
Phoenix, Arizona, 85016
PPD Bioanalytical
Richmond, Virginia, 23230
St. Joseph's Hospital
Tampa, Florida, 33607
Jacobi Medical Center
The Bronx, New York, 10461
Brazil8 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Multihemo Servicos Medicos S/A
Recife, Pernambuco, 50070-460
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, 20211-030
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Casa de Saude Santa Marcelina
São Paulo, São Paulo, 08270-070
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP
São Paulo, 05403-000
CEPEC-Centro de Pesquisa Clinica
São Paulo, 08270-120
Nigeria8 sites
National Hospital Abuja
Abuja, Federal Capital Territory, 900211
University of Calabar Teaching Hospital
Calabar, Cross River State, 540242
University of Nigeria Teaching Hospital
Enugu, 460000
University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory, 902101
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, 800212
Aminu Kano Teaching Hospital
Kano, 700223
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos, 100254
Ahmadu Bello University Teaching Hospital (ABUTH)
Zaria, Kaduna State, 810107
Italy6 sites
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
Genova, Genoa, 16128
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
Genova, 16128
DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitell
Naples, 80138
UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria
Naples, 80138
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Naples, 80138
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Naples, 80138
Kenya4 sites
International Cancer Institute
Eldoret, 30100
Kemri/Crdr, Siaya, Kemri Clinical Research Annex,
Kisumu, Siaya County, 40600
Kenya medical Research Institute-centre for Respiratory Disease Research
Nairobi, 00100
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
Nairobi, 00200
Turkey (Türkiye)4 sites
Baskent University Hospital
Adana, Yuregir, 01250
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana, 01130
Hacettepe University
Ankara, Altindag/sihhiye, 06230
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
Yenischir, Mersin, Mersin, 33343
Colombia2 sites
Clinica de la Costa Ltda.
Barranquilla, Atlántico, 080020
Organizacion Clinica Bonnadona Prevenir S.A.S.
Barranquilla, Atlántico, 080020
France2 sites
Hopital Avicenne
Bobigny, 93000
Hopital Henri Mondor
Créteil, 94010
Lebanon2 sites
American University of Beirut Medical Center
Hamra, Beirut
Nini Hospital
Tripoli, North Lebanon
Zambia2 sites
Matero Clinical Research Site,
Lusaka, 10101
University Teaching Hospital- Children's Hospital
Lusaka, 10101
Germany1 site
Universitatsklinikum Regensburg Padiatrische Hamatologie, Onkologie und Stammzelltransplantation
Regensburg, 93053
Saudi Arabia1 site
Prince Mohammed bin Nasser Hospital
Jizan, Southern, 82943
United Kingdom1 site
Guy's & Thomas' NHS Foundation Trust
London, England, SE1 9RT
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
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.
Read the detailed description
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.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease
- Being tested
- Inclacumab, Placebo
- Keywords
- Re-admission, Acute, blood disorders, hemoglobin, red blood cells, RBCs, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, Sickle Cell Disease, SCD, Vaso-occlusive Crisis, VOC, SCA
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Hematologic Diseases, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclacumabDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| inclacumab 30 mg/kg | Experimental | Inclacumab 30 mg/kg administered intravenously (IV) Receives: Drug: Inclacumab |
| placebo | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start9 Dec 2021
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Why it stopped: Study was terminated due to poor accrual and associated recrutiment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927247
- Sponsor's protocol ID
- GBT2104-132
- Other IDs
- C5361002, 2020-005287-60, 2020-005287-60
- Status last verified
- Nov 2024
- First submitted
- 26 May 2021
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
- ClinicalTrials.gov ID
- NCT04927247
- Acronym / sponsor ID
- GBT2104-132
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease
- Keywords
- Re-admission, Acute, blood disorders, hemoglobin, red blood cells, RBCs, sickle-like shape, mutation in hemoglobin gene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to poor accrual and associated recrutiment challenges
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inclacumab 30 mg/kg | Experimental | Drug: InclacumabInclacumab 30 mg/kg administered intravenously (IV) |
| placebo | Placebo comparator | Drug: PlaceboPlacebo administered IV |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (4 listed)
- 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 Screening.
- Participant weighs > 133 kg (292 lbs.).
- Other protocol-defined Inclusion/Exclusion may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclacumabInclacumab 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. | Drug | inclacumab 30 mg/kg |
| PlaceboPlacebo 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. | Drug | placebo |
Primary outcome
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
Time frame: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])
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.
3 secondary outcomes
Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization
Time frame: 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
Time frame: 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
Time frame: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
59 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclacumab in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Pfizer at 59 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Brazil, Nigeria, Italy, Kenya and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.