NCT05469828Not yet recruitingPhase 1/2
Crizanlizumab Improves Tissue Oxygen Supply Demand Matching in Patients With Sickle Cell Anemia
Source: ClinicalTrials.gov · Last updated 30 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Hypothesis Efficient unloading of oxygen to regions of high metabolic demand requires a healthy microvasculature to sense local oxygen tension and regulate flow, accordingly. In sickle cell disease patients, the investigators have demonstrated oxygen supply-demand mismatch, or SDM, in proportion to anemia severity. SDM occurs in both the peripheral circulation and the brain, and four characteristics: 1) Hyperemia beyond expected for the level of anemia, 2) Corresponding loss of vascular dilatory reserve, 3) Impaired oxygen unloading to the tissues, and 4) Tissue hypoxia. In sickle cell disease, red blood cell (RBC) and white blood cell (WBC) adhere to vascular endothelium triggering transient or irreversible microvascular damage as well as releasing vasoactive substances that contribute to microvascular dysregulation. The investigators postulate that ongoing microvascular damage/dysregulation in the setting of increased total blood flow contributes to SDM. The investigators believe SEG101, by lowering RBC and WBC adhesion to the microvasculature, will improve SDM and tissue oxygenation. Objectives * Primary - The investigators will test whether SEG101 improves SDM in patients with sickle cell anemia by measuring the change in tissue oxygenation measured by near infrared spectroscopy (NIRS). * Secondary/Exploratory - The investigators will identify end-organ disease and whether improvement of SDM by SEG101 occurs in patients with sickle cell anemia.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 31 Aug 2021
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Children's Hospital Los Angeles
- Diseases
- Sickle cell disease
- NCT number
- NCT05469828
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 1 Jul 2024 to the primary completion date, 1 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any pain crisis requiring an ER visit and/or admission to the hospital and/or required parenteral pain medication in the previous 4 weeks.
- Any acute transfusion in the previous 4 weeks
- Need for chronic transfusion therapy
Other illness
- Any known chronic illness that in the judgment of the investigator may compromise subject safety or data integrity. These include but are not limited to rheumatologic disorders, malignancy, severe asthma, chronic hepatic or renal insufficiency.
- Seizure disorder
Other
- Known pregnancy
- Inability to cooperate with MRI examinations
- Contraindication to Crizanlizumab
Who the study is looking for
- We will enroll only SS and Sß0 sickle cell disease patients
- Both male and female will be included.
- Our population of sickle cell disease is 90% African American and 10% Hispanic, therefore, our study population will reflect that distribution of ethnicity.
- Informed consent from legal guardian and/or patient
- Able to participate without needing sedation for MRI scan
- Age at least 16 years
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.