Sickle Cell DiseaseNCT05407805
A Study to Learn About Sickle Cell Disease In Adult Patients
An observational study of Sickle Cell Disease, run by Pfizer at 4 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate the performance of the sickle cell disease (SCD) electronic diary in people with SCD who are on treatment that will change SCD and those not on such a treatment. SCD is a type of condition when there are fewer red blood cells to carry oxygen around the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Electronic Diary
- How many people
- 98 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Feb 2022to 24 Jun 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a confirmed diagnosis of stable Sickle Cell Disease (SCD) (hemoglobin S inherited from both parents [HbS/S] or hemoglobin S inherited from one parent and hemoglobin beta thalassemia inherited from the other parent [HbS/beta-zero-thalassemia] genotype) who are either not on disease modifying treatment or on a stable dose of a SCD disease modifying treatment regimen.
Who may be able to join
- Confirmed diagnosis of stable SCD (HbS/S or HbS/beta-zero-thalassemia).
- Additional Inclusion Criteria (No Disease Modifying Treatment Control Group):
- Have experienced ≥1 episode(s) of medical utilization (MU) VOC within 12 months prior to Screening.
- Data available for number of MU VOC(s) during the 12-month interval prior to Screening and a value for %fetal hemoglobin (HbF) collected subsequent to 1 year of age in the absence of recent transfusion.
- Additional Inclusion Criteria (SCD Disease Modifying Treatment Group):
- Have experienced ≥1 episode(s) of MU VOC within 12 months prior to initiation of HU and/or crizanlizumab (whichever was initiated earlier).
Show all 10Show fewer
- Must be on a stable dose of their SCD treatment regimen ≥8 weeks prior to Day 1 with the intent of remaining on the same dose throughout the study, unless adjustments are medically necessary due to bone marrow suppression, in accordance with published guidelines and/or product specific guidance (eg, package label). Accepted SCD disease modifying treatment regimens include:
- HU alone and/or in combination with crizanlizumab, L-glutamine and/or voxelotor; or
- Crizanlizumab alone and/or in combination with HU, L-glutamine and/or voxelotor.
- Data available for number of MU VOC(s) during the 12-month interval prior to initiation of any SCD disease modifying treatment, as described above, and a value for %HbF collected subsequent to 1 year of age, prior to initiation of any HU treatment, and in the absence of recent transfusion.
Who cannot join
- Evidence or history of ongoing (condition or sequelae) clinically significant hematological (non-SCD), renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including overt stroke but excluding silent cerebral infarct), hepatic (excluding cholelithiasis), psychiatric or neurological disease as assessed from medical records.
- Marked ongoing bone marrow suppression as evidenced by any of the following as per medical record: severe anemia, absolute neutrophil count (ANC) <1000 mm3 white blood cell (WBC), thrombocytopenia (platelet count <100,000 mm3) within ≤8 weeks prior to Day 1 enrollment.
- History of hematopoietic stem cell transplant or treatment with gene therapy as assessed from medical records.
- History of simple transfusion within ≤4 weeks prior to Day 1 enrollment as assessed from medical records or participant self-report.
- History of chronic transfusion/exchange transfusion within ≤12 weeks prior to Day 1 enrollment as assessed from medical records or participant self-report and/or plan to initiate such treatment during the 6-month observation period.
- Additional Exclusion Criteria (No Disease Modifying Treatment Control Group):
- Participant received HU and/or crizanlizumab at any time within ≤18 months of Day 1 enrollment and treatment(s) was discontinued due to lack of efficacy (no reduction in the frequency of VOCs, documented or perceived) and/or plan to initiate said treatment(s) during the 6-month observation period.
- Participant received voxelotor or L-glutamine within ≤4 weeks of Day 1 enrollment and/or plan to initiate said treatment(s) during the 6-month observation period.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33024
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Mid-Atlantic Permanente Medical Group Largo Medical Center
Upper Marlboro, Maryland, 20774
Sanguine Biosciences, Inc.
Waltham, Massachusetts, 02451
About this study
Official title: A LOW-INTERVENTIONAL LONGITUDINAL STUDY OF AN ELECTRONIC SICKLE CELL DISEASE PATIENT REPORTED OUTCOMES IN ADULT PARTICIPANTS AGED ≥18 YEARS OF AGE ON AND OFF HYDROXYUREA
The purpose of this clinical trial is to evaluate the performance of the sickle cell disease (SCD) electronic diary in people with SCD who are on treatment that will change SCD and those not on such a treatment.
SCD is a type of condition when there are fewer red blood cells to carry oxygen around the body.
Read more
This disease can be passed on from parent to child and may cause pain, infections and damage to organs.
This study is seeking participants who:
- are confirmed with SCD
- are on a stable regimen of disease changing treatment or have not received any disease changing treatment before the start of the study and do not plan any changes in their treatment during the 6-month study observation period For 6 months, participants will be asked to complete a daily electronic diary to report on their experience in the past 24 hours with sickle cell pain crisis (if they got any treatment and what medications they took), worst pain, worst tiredness, and their ability to perform usual physical activities. We will compare the experiences of people who are taking SCD-modifying therapy to those that are not taking a SCD-modifying therapy.
- Conditions
- Sickle Cell Disease
- Being tested
- Electronic Diary
- Keywords
- Vaso-occlusive crisis (VOC), Hemoglobin S (HbS)
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic DiaryOther
Also called SCD electronic patient reported outcome (ePRO)
Participants will be asked to complete a daily electronic patient reported outcome diary entry to report on their experience in the past 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | SCD participants not on disease modifying treatment. Receives: Other: Electronic Diary | |
| SCD Disease Modifying Treatment Group | SCD participants on a stable dose of a SCD disease modifying treatment regimen. Receives: Other: Electronic Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician-reported Medical Utilization (MU) Vaso-occlusive Crisis (VOC) Rate
Physician-reported MU VOC: defined as an acute episode of pain with no other cause other than a VOC event that required a medical facility visit or contact with a health care professional and treatment with oral or parenteral narcotics, or non-steroidal anti-inflammatory drugs. Acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism (requiring a visit to a medical facility) were also considered MU VOC. Contact with healthcare professional included: called healthcare provider (or telemedicine visit) and received treatment, went to clinic and received treatment, went to emergency department and received treatment, admitted to the hospital and received treatment. VOC rate was derived as annualized rate. Annualized MU VOC rate = (Number of MU VOC events * 365)/ (number of days in the observation period).
Measured: Baseline up to Day 180
VOC Day Rate
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was a self-report by the participant of experiencing a VOC during the past 24 hours. This was assessed through a dichotomous (Yes/No) item on the SCD ePRO system, "Did you have a pain crisis in the past 24 hours?" A response of "Yes" indicated a VOC day. VOC day rate was derived as annualized rate. VOC day rate = (Number of VOC days * 365)/ (number of days in the observation period).
Measured: Baseline up to Day 180
Patient-reported VOC Event Rate
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. Patient reported VOC Event is used to define a sequence of VOC days that could also include single intervening days with no pain crisis. The subsequent occurrence of two consecutive days with no pain crisis operationally defines the end of the respective VOC event. Rate were derived as annualized rate. Annualized VOC event rate = (Number of VOC events * 365)/ (number of days in the observation period).
Measured: Baseline up to Day 180
Sickle Cell Disease (SCD) Electronic Patient Reported Outcome (ePRO) Daily Worst Pain Scores by VOC Status
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was defined as the day on which a SCD participant self-reports sickle pain crisis that was recorded in the SCD ePRO. A non-VOC day was defined as the day on which a SCD participant does not self-reports sickle pain crisis. Participants rated their pain by selecting the one number that best described their pain at its worst in the past 24 hours from 0-10, where 0= no pain and 10= as bad as you can imagine. Higher scores indicated worse pain. Data in this outcome measure was presented separately for VOC state and non-VOC state.
Measured: Baseline up to Day 180
Sickle Cell Disease Electronic Patient Reported Outcome Daily Worst Tiredness Scores by VOC Status
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was defined as the day on which a SCD participant self-reports sickle pain crisis that was recorded in the SCD ePRO. A non-VOC day was defined as the day on which a SCD participant does not self-reports sickle pain crisis. Participants rated their tiredness by selecting the one number that best described their tiredness at its worst in the past 24 hours from 0-10, where 0= no tiredness and 10= as bad as you can imagine. Higher scores indicated worse tiredness. Data in this outcome measure was presented separately for VOC state and non-VOC state.
Measured: Baseline up to Day 180
Sickle Cell Disease Electronic Patient Reported Outcome Daily Rating for Ability to Perform Usual Physical Activity (UPA) by VOC Status
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was defined as the day on which a SCD participant self-reports sickle pain crisis that was recorded in the SCD ePRO. A non-VOC day was defined as the day on which a SCD participant does not self-reports sickle pain crisis. A measure of participant's ability to perform their UPA (e.g. walking, climbing stairs, or household chores) during a VOC event was assessed on SCD ePRO recorded by participants using a scale ranging from 1-4 scale, where 1= able to perform with no difficulty and 4= unable to perform usual physical activities, where higher score indicated worse status. Data in this outcome measure was presented separately for VOC state and non-VOC state.
Measured: Baseline up to Day 180
Secondary outcomes (2)
Percent Change in Physician-reported MU VOC Rate Per Unit of Change in VOC Day Rate
MU VOC: acute episode of pain with no other cause other than VOC event that required medical facility visit/contact with health care professional and treatment with oral/parenteral narcotics/NSAIDs. Acute chest syndrome,hepatic/splenic sequestration, priapism also considered MU VOC. MU VOC derived as annualized rate by:(Number of MU VOC events*365)/(number of days in observation period). VOC day rate: VOC day was self-report by participant experiencing VOC during past 24 hours. It was assessed by dichotomous (Yes/No) item on SCD ePRO system, "Did you have pain crisis in past 24 hours?" Response "Yes" indicated VOC day. VOC day rate derived as annualized rate by: (Number of VOC days*365)/(number of days in observation period). Parameter of interest was % change of MU VOC rate per unit of change in VOC Day rate. It was estimated via Negative Binomial model to evaluate association between physician-reported MU VOC rate and SCD ePRO VOC Day rate and was reported with corresponding 95% CI.
Measured: Baseline up to Day 180
Percent Change in Physician-reported MU VOC Rate Per Unit of Change in Patient-reported VOC Event Rate
MU VOC: acute episode of pain with no other cause other than VOC event that required medical facility visit/contact with health care professional and treatment with oral/parenteral narcotics/NSAIDs. Acute chest syndrome, hepatic/splenic sequestration, priapism also considered MU VOC. MU VOC derived as annualized rate by:(Number of MU VOC events*365)/(number of days in observation period). VOC Event rate: Patient-reported VOC Event is used to define a sequence of VOC days. The subsequent occurrence of two consecutive days with no pain crisis operationally defines the end of the respective VOC event. Rate were derived as annualized rate by: (Number of VOC events * 365)/ (number of days in the observation period). Parameter of interest was % change of MU VOC rate per unit of change in VOC Event rate. It was estimated via Negative Binomial model to evaluate association between physician-reported MU VOC rate and SCD ePRO VOC Event rate and was reported with corresponding 95% CI.
Measured: Baseline up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start10 Feb 2022
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 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
- NCT05407805
- Sponsor's protocol ID
- C4071008
- Other IDs
- NCT05407805
- Status last verified
- May 2026
- First submitted
- 18 May 2022
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A LOW-INTERVENTIONAL LONGITUDINAL STUDY OF AN ELECTRONIC SICKLE CELL DISEASE PATIENT REPORTED OUTCOMES IN ADULT PARTICIPANTS AGED ≥18 YEARS OF AGE ON AND OFF HYDROXYUREA
- ClinicalTrials.gov ID
- NCT05407805
- Acronym / sponsor ID
- C4071008
- Conditions
- Sickle Cell Disease
- Keywords
- Vaso-occlusive crisis (VOC), Hemoglobin S (HbS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the performance of the sickle cell disease (SCD) electronic diary in people with SCD who are on treatment that will change SCD and those not on such a treatment.
SCD is a type of condition when there are fewer red blood cells to carry oxygen around the body.
This disease can be passed on from parent to child and may cause pain, infections and damage to organs.
This study is seeking participants who:
- are confirmed with SCD
- are on a stable regimen of disease changing treatment or have not received any disease changing treatment before the start of the study and do not plan any changes in their treatment during the 6-month study observation period For 6 months, participants will be asked to complete a daily electronic diary to report on their experience in the past 24 hours with sickle cell pain crisis (if they got any treatment and what medications they took), worst pain, worst tiredness, and their ability to perform usual physical activities. We will compare the experiences of people who are taking SCD-modifying therapy to those that are not taking a SCD-modifying therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Electronic DiarySCD participants not on disease modifying treatment. |
| SCD Disease Modifying Treatment Group | – | Other: Electronic DiarySCD participants on a stable dose of a SCD disease modifying treatment regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a confirmed diagnosis of stable Sickle Cell Disease (SCD) (hemoglobin S inherited from both parents [HbS/S] or hemoglobin S inherited from one parent and hemoglobin beta thalassemia inherited from the other parent [HbS/beta-zero-thalassemia] genotype) who are either not on disease modifying treatment or on a stable dose of a SCD disease modifying treatment regimen.
Key inclusion criteria (10 listed)
- Confirmed diagnosis of stable SCD (HbS/S or HbS/beta-zero-thalassemia).
- Have experienced ≥1 episode(s) of medical utilization (MU) VOC within 12 months prior to Screening.
- Data available for number of MU VOC(s) during the 12-month interval prior to Screening and a value for %fetal hemoglobin (HbF) collected subsequent to 1 year of age in the absence of recent transfusion.
- Have experienced ≥1 episode(s) of MU VOC within 12 months prior to initiation of HU and/or crizanlizumab (whichever was initiated earlier).
- Must be on a stable dose of their SCD treatment regimen ≥8 weeks prior to Day 1 with the intent of remaining on the same dose throughout the study, unless adjustments are medically necessary due to bone marrow suppression, in accordance with published guidelines and/or product specific guidance (eg, package label). Accepted SCD disease modifying treatment regimens include:
Key exclusion criteria (8 listed)
- Evidence or history of ongoing (condition or sequelae) clinically significant hematological (non-SCD), renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including overt stroke but excluding silent cerebral infarct), hepatic (excluding cholelithiasis), psychiatric or neurological disease as assessed from medical records.
- Marked ongoing bone marrow suppression as evidenced by any of the following as per medical record: severe anemia, absolute neutrophil count (ANC) <1000 mm3 white blood cell (WBC), thrombocytopenia (platelet count <100,000 mm3) within ≤8 weeks prior to Day 1 enrollment.
- History of hematopoietic stem cell transplant or treatment with gene therapy as assessed from medical records.
- History of simple transfusion within ≤4 weeks prior to Day 1 enrollment as assessed from medical records or participant self-report.
- History of chronic transfusion/exchange transfusion within ≤12 weeks prior to Day 1 enrollment as assessed from medical records or participant self-report and/or plan to initiate such treatment during the 6-month observation period.
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 |
|---|---|---|
| Electronic DiaryAlso: SCD electronic patient reported outcome (ePRO)Participants will be asked to complete a daily electronic patient reported outcome diary entry to report on their experience in the past 24 hours. | Other | Control Group, SCD Disease Modifying Treatment Group |
Primary outcome
Physician-reported Medical Utilization (MU) Vaso-occlusive Crisis (VOC) Rate
Time frame: Baseline up to Day 180
Physician-reported MU VOC: defined as an acute episode of pain with no other cause other than a VOC event that required a medical facility visit or contact with a health care professional and treatment with oral or parenteral narcotics, or non-steroidal anti-inflammatory drugs. Acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism (requiring a visit to a medical facility) were also considered MU VOC. Contact with healthcare professional included: called healthcare provider (or telemedicine visit) and received treatment, went to clinic and received treatment, went to emergency department and received treatment, admitted to the hospital and received treatment. VOC rate was derived as annualized rate. Annualized MU VOC rate = (Number of MU VOC events * 365)/ (number of days in the observation period).
VOC Day Rate
Time frame: Baseline up to Day 180
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was a self-report by the participant of experiencing a VOC during the past 24 hours. This was assessed through a dichotomous (Yes/No) item on the SCD ePRO system, "Did you have a pain crisis in the past 24 hours?" A response of "Yes" indicated a VOC day. VOC day rate was derived as annualized rate. VOC day rate = (Number of VOC days * 365)/ (number of days in the observation period).
Patient-reported VOC Event Rate
Time frame: Baseline up to Day 180
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. Patient reported VOC Event is used to define a sequence of VOC days that could also include single intervening days with no pain crisis. The subsequent occurrence of two consecutive days with no pain crisis operationally defines the end of the respective VOC event. Rate were derived as annualized rate. Annualized VOC event rate = (Number of VOC events * 365)/ (number of days in the observation period).
Sickle Cell Disease (SCD) Electronic Patient Reported Outcome (ePRO) Daily Worst Pain Scores by VOC Status
Time frame: Baseline up to Day 180
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was defined as the day on which a SCD participant self-reports sickle pain crisis that was recorded in the SCD ePRO. A non-VOC day was defined as the day on which a SCD participant does not self-reports sickle pain crisis. Participants rated their pain by selecting the one number that best described their pain at its worst in the past 24 hours from 0-10, where 0= no pain and 10= as bad as you can imagine. Higher scores indicated worse pain. Data in this outcome measure was presented separately for VOC state and non-VOC state.
Sickle Cell Disease Electronic Patient Reported Outcome Daily Worst Tiredness Scores by VOC Status
Time frame: Baseline up to Day 180
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was defined as the day on which a SCD participant self-reports sickle pain crisis that was recorded in the SCD ePRO. A non-VOC day was defined as the day on which a SCD participant does not self-reports sickle pain crisis. Participants rated their tiredness by selecting the one number that best described their tiredness at its worst in the past 24 hours from 0-10, where 0= no tiredness and 10= as bad as you can imagine. Higher scores indicated worse tiredness. Data in this outcome measure was presented separately for VOC state and non-VOC state.
Sickle Cell Disease Electronic Patient Reported Outcome Daily Rating for Ability to Perform Usual Physical Activity (UPA) by VOC Status
Time frame: Baseline up to Day 180
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. VOC day was defined as the day on which a SCD participant self-reports sickle pain crisis that was recorded in the SCD ePRO. A non-VOC day was defined as the day on which a SCD participant does not self-reports sickle pain crisis. A measure of participant's ability to perform their UPA (e.g. walking, climbing stairs, or household chores) during a VOC event was assessed on SCD ePRO recorded by participants using a scale ranging from 1-4 scale, where 1= able to perform with no difficulty and 4= unable to perform usual physical activities, where higher score indicated worse status. Data in this outcome measure was presented separately for VOC state and non-VOC state.
2 secondary outcomes
Percent Change in Physician-reported MU VOC Rate Per Unit of Change in VOC Day Rate
Time frame: Baseline up to Day 180
Percent Change in Physician-reported MU VOC Rate Per Unit of Change in Patient-reported VOC Event Rate
Time frame: Baseline up to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- 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: No. 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Pfizer at 4 sites in United States.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). 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?
Physician-reported Medical Utilization (MU) Vaso-occlusive Crisis (VOC) Rate (time frame: Baseline up to Day 180). The study lists 6 primary outcomes in all. 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 10 Jun 2026.