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CLINICAL TRIALS PROFILE FOR VOXELOTOR
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All Clinical Trials for Voxelotor
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03573882 | Study to Assess the Effect of Long-term Treatment With GBT440 in Participants Who Have Completed Treatment in Study GBT440-031 | Enrolling by invitation | Global Blood Therapeutics | Phase 3 | 2018-06-06 | Open Label Extension Study of GBT440 Clinical Trial Patients with Sickle Cell Disease Who Participated in GBT440 Clinical Trials |
| NCT04000165 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Oral Doses of AG-348 in Subjects With Stable Sickle Cell Disease | Recruiting | National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 | 2019-07-02 | 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) o 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 7 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 4 visits participants will stay at the clinic for up to 2 nights. Participants will take study drug in increasing doses for 6 weeks, 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. |
| NCT04188509 | Pediatric Open-Label Extension of Voxelotor | Enrolling by invitation | Global Blood Therapeutics | Phase 3 | 2019-11-18 | Open-label extension study of voxelotor for pediatric participants ages 4 to 18 years old with Sickle Cell Disease who have participated in voxelotor clinical trials. |
| NCT04218084 | Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease | Not yet recruiting | Global Blood Therapeutics | Phase 3 | 2020-02-01 | This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to < 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range. |
| NCT04247594 | Dose Escalation Study to Evaluate the Safety, Tolerability, PK and PD of Voxelotor in Patients With SCD | Recruiting | Global Blood Therapeutics | Phase 2 | 2020-01-09 | This is a dose escalation study to evaluate the safety and tolerability of voxelotor at daily doses of 1500 mg to 3000 mg in participants with sickle cell disease (SCD). The study is designed to include 2 separate cohorts. In Cohort A participants will undergo up to 4 periods of voxelotor administration at progressively higher dose levels from 1500 mg until either a maximum tolerated dose (MTD) or 3000 mg orally daily is reached. Cohort B (following Cohort A) will assess the tolerability and safety of doses higher than 1500 mg administered without up-titration. |
| NCT04335721 | A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease | Not yet recruiting | Global Blood Therapeutics | Phase 1/Phase 2 | 2020-04-01 | This study is a single center, prospective exploratory pilot study of Sickle Cell Anemia (SCA) participants. The study will enroll patients with early stages of sickle cell nephropathy (Chronic Kidney Disease (CKD) stage 1 or 2) who are at the highest risk of CKD progression (presence of both hemoglobinuria and urine albumin concentration ≥ 30 mg/g creatinin |
| NCT04335721 | A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease | Not yet recruiting | University of Illinois at Chicago | Phase 1/Phase 2 | 2020-04-01 | This study is a single center, prospective exploratory pilot study of Sickle Cell Anemia (SCA) participants. The study will enroll patients with early stages of sickle cell nephropathy (Chronic Kidney Disease (CKD) stage 1 or 2) who are at the highest risk of CKD progression (presence of both hemoglobinuria and urine albumin concentration ≥ 30 mg/g creatinin |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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