CLINICAL TRIALS PROFILE FOR OXBRYTA
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All Clinical Trials for oxbryta
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04000165 ↗ | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Oral Doses of AG-348 in Subjects With Stable Sickle Cell Disease | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Early Phase 1 | 2019-07-11 | Background: Sickle Cell Disease (SCD) is an inherited blood disorder. People with SCD have abnormal hemoglobin in their red blood cells. Researchers are investigating the safety and efficacy of an investigational medicine called AG-348 (mitapivat sulfate) to determine if it will help people with SCD. Objective: To test the tolerability and safety of AG-348 in people with SCD. Eligibility: People ages 18 and older with SCD. Design: Participants will have 8 visits over approximately 14 weeks. At the first visit participants will be screened with a medical history; a physical exam; and blood, urine, and heart tests. At the following 5 visits participants will stay at the clinic for 1 night each. Participants will take study drug in increasing doses upto visit 6, after which the drug will be tapered off. All visits will include physical exam, blood, and urine tests. The last visit will occur 4 weeks after stopping the drug and also includes a heart test. Participants will provide DNA from the blood samples they provide. The DNA will be tested for an inherited gene that can cause differences in response to the study drug. Researchers may also test other genes to see if they can find any genes that interact with SCD. |
| NCT04000165 ↗ | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Oral Doses of AG-348 in Subjects With Stable Sickle Cell Disease | Completed | National Institutes of Health Clinical Center (CC) | Early Phase 1 | 2019-07-11 | Background: Sickle Cell Disease (SCD) is an inherited blood disorder. People with SCD have abnormal hemoglobin in their red blood cells. Researchers are investigating the safety and efficacy of an investigational medicine called AG-348 (mitapivat sulfate) to determine if it will help people with SCD. Objective: To test the tolerability and safety of AG-348 in people with SCD. Eligibility: People ages 18 and older with SCD. Design: Participants will have 8 visits over approximately 14 weeks. At the first visit participants will be screened with a medical history; a physical exam; and blood, urine, and heart tests. At the following 5 visits participants will stay at the clinic for 1 night each. Participants will take study drug in increasing doses upto visit 6, after which the drug will be tapered off. All visits will include physical exam, blood, and urine tests. The last visit will occur 4 weeks after stopping the drug and also includes a heart test. Participants will provide DNA from the blood samples they provide. The DNA will be tested for an inherited gene that can cause differences in response to the study drug. Researchers may also test other genes to see if they can find any genes that interact with SCD. |
| NCT04400487 ↗ | Actigraphy Improvement With Voxelotor (ActIVe) Study | Recruiting | Global Blood Therapeutics | Phase 4 | 2020-10-23 | This is a study to evaluate the effect of voxelotor on daily physical activity and sleep quality, as measured by a wrist-worn device in participants with sickle cell disease (SCD) and chronic moderate anemia. |
| NCT05018728 ↗ | The Effect of Voxelotor on Cerebral Hemodynamic Response in Children With Sickle Cell Anemia | Not yet recruiting | Global Blood Therapeutics | Phase 2 | 2021-09-01 | Voxelotor is a new drug for adolescents and adults with sickle cell disease that improves hemoglobin levels and reduces the incidence of worsening anemia. However, it is unclear whether this increase in hemoglobin is associated with a reduction in cerebral metabolic stress. This study will measure the effects of voxelotor on cerebral hemodynamics. |
| NCT05018728 ↗ | The Effect of Voxelotor on Cerebral Hemodynamic Response in Children With Sickle Cell Anemia | Not yet recruiting | Emory University | Phase 2 | 2021-09-01 | Voxelotor is a new drug for adolescents and adults with sickle cell disease that improves hemoglobin levels and reduces the incidence of worsening anemia. However, it is unclear whether this increase in hemoglobin is associated with a reduction in cerebral metabolic stress. This study will measure the effects of voxelotor on cerebral hemodynamics. |
| NCT05228821 ↗ | Voxelotor Cerebral Hemodynamics Study | Not yet recruiting | Global Blood Therapeutics | Phase 4 | 2022-02-01 | This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the impact of voxelotor treatment on cerebral blood flow (CBF) in adult and adolescent participants (12-30 years of age) with sickle cell disease (SCD). |
| NCT05981365 ↗ | Voxelotor CYP and Transporter Cocktail Interaction Study | Completed | Pfizer | Phase 1 | 2023-04-17 | This research study is examining multiple doses of voxelotor (a study drug intended for treatment of sickle cell disease) and how it interacts with additional substrates (substrates are drugs or other substances that are metabolized by cytochrome enzymes. The substrates used in this study are FDA approved medications). The study will help to determine the safety and tolerability of the study drugs taken together, as well as the pharmacokinetics (PK) on how your body processes and responds to the combination of the study drug and substrates. Although these drugs are FDA approved, their use in this study is experimental. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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