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New eDiary helps track sickle cell pain and fatigue

NCT ID NCT05407805

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an electronic diary for adults with sickle cell disease to track daily symptoms like pain, tiredness, and ability to do usual activities. About 98 participants used the diary for 6 months, and researchers compared those on disease-modifying treatment to those not on any. The goal was to see how well the diary captures real-world experiences of sickle cell crises.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

98 people

The number who actually took part.

Started

Feb 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (All Groups): \- 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). * 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. Exclusion Criteria (All Groups): * 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.

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Conditions

The condition(s) this trial relates to.

sickle cell disease Sickle Cell Trait Vaso-Occlusive Crises

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040, United States

  • Foundation for Sickle Cell Disease Research

    Hollywood, Florida, 33024, United States

  • Mid-Atlantic Permanente Medical Group Largo Medical Center

    Upper Marlboro, Maryland, 20774, United States

  • Sanguine Biosciences, Inc.

    Waltham, Massachusetts, 02451, United States

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Other studies related to the condition(s) this trial covers.