NCT06023199CompletedPhase 2
Assessing Physical Function in Sickle Cell Patients Taking Voxelotor
Assessing Functional Capacity in Sickle Cell Patients Receiving Voxelotor
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
Voxelotor is a novel hemoglobin polymerization inhibitor which has been demonstrated to reduce hemolysis and improve hemoglobin levels. There have been numerous studies examining the clinical impact of voxelotor in sickle cell disease (SCD) patients, but there are few published reports on the effects of treatment on physical function in patients with SCD. The hypothesis to be tested is that anemic SCD patients will have improvements in performance after 6 months of voxelotor treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 7 Aug 2023
- Start date
- 23 Oct 2023
- Primary completion date
- 17 Sept 2025
- Lead sponsor
- Inova Health Care Services
- Diseases
- Sickle cell disease
- NCT number
- NCT06023199
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 23 Oct 2023 to the primary completion date, 17 Sept 2025
- 1 site in 1 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
- Patients receiving hydroxyurea who have had a dose change within the prior 3 months
- Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) within 30 days of 6MWT
- Current or previous diagnosis of malignancy within the last two years excluding local therapy for non-melanoma skin malignancy
- Unstable cardiopulmonary disease within the last 6 months prior to study enrollment
- Prior hypersensitivity to voxelotor or its excipients
Other illness
- Acute kidney injury or chronic renal disease with estimated glomerular filtration rate\<30mL/min/1.73 m2
- Any conditions including behavioral or medical that in the opinion of the investigator, may negatively impact informed consent, participation and study interpretation
Lab values
- Hemoglobin results \< 6 g/dL or \> 10.5 g/dL
- Any form of hepatic dysfunction as demonstrated by alanine aminotransferase (ALT) \>4 × ULN or Child-Pugh Class C
Other
- Females who are breastfeeding or pregnant
- Current use of commercially available voxelotor
- Patients with baseline gait and other physical impairments that would limit 6MWT and other functional assessment at discretion of the investigator
- Patients who on day of assessment present with vaso-occlusive crisis or rate their pain greater than 6 on a scale of 1-10 using the Numeric Rating Scale will not be assessed that day and re-screened at the investigator's discretion.
Who the study is looking for
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female,
- aged 18-65 years
- Diagnosis of sickle cell disease with HbSS, HbSc, HbS-beta thalassemia genotypes
- Hemoglobin level of 6 g/dL - 10.5 g/dL
- Between 0 and 10 vaso-occlusive (VOC) episodes in previous 12 months
- Ability to take oral medication and be willing to adhere to the voxelotor regimen
- For females of reproductive potential, they will be educated to avoid pregnancy during study period and for one month after due to limited data surrounding pregnancy and voxelotor
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.