10 completed, 4 terminated, 2 no longer available. 7 Phase 1, 3 Phase 2, 3 Phase 3, 1 Phase 4.
By phase and status
Follow GBT440: new trials by email Literature Review of GBT440 trials Research Report on GBT440
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
Actigraphy Improvement With Voxelotor (ActIVe) Study Voxelotor - Sickle Cell Disease, Sickle Cell Anemia | Phase 4 | Completed | 25 | 2020-12-21 | 2023-11-21 |
Open-Label Extension of Voxelotor Voxelotor - Sickle Cell Disease | Phase 3 | Terminated | 162 | 2019-11-18 | 2025-11-13 |
Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031 Voxelotor - Sickle Cell Disease | Phase 3 | Terminated | 179 | 2018-06-06 | 2025-11-18 |
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment GBT440 - Hepatic Impairment | Phase 1 | Completed | 29 | 2017-03-17 | 2023-07-18 |
Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions GBT440 - Cardio-pulmonary Function | Phase 1 | Terminated | 14 | 2016-12-01 | 2019-10-04 |
Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) voxelotor, Placebo - Sickle Cell Disease | Phase 3 | Completed | 449 | 2016-12-01 | 2023-07-27 |
Single-Dose PK Study of GBT440 in Subjects With Renal Impairment GBT440 - Renal Impairment | Phase 1 | Completed | 16 | 2016-11-01 | 2018-02-22 |
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest GBT440 - Idiopathic Pulmonary Fibrosis, Hypoxemia | Phase 2 | Terminated | 14 | 2016-11-01 | 2020-08-21 |
An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001 GBT440 - Sickle Cell Disease | Phase 2 | Completed | 5 | 2016-08-01 | 2019-01-02 |
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF GBT440, Placebo - Idiopathic Pulmonary Fibrosis, Hypoxemia | Phase 2 | Completed | 39 | 2016-06-01 | 2020-10-20 |
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects GBT440 - Sickle Cell Disease | Phase 1 | Completed | 24 | 2015-09-01 | 2017-04-12 |
A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects GBT440 - Sickle Cell Disease | Phase 1 | Completed | 26 | 2015-09-01 | 2017-04-12 |
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects GBT440 - Anemia, Sickle Cell | Phase 1 | Completed | 7 | 2015-06-01 | 2017-04-12 |
A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease GBT440, Placebo - Healthy Subjects, Sickle Cell Disease | Phase 1 | Completed | 133 | 2014-12-01 | 2018-02-15 |
Expanded Access Protocol for Adults and Pediatric Patients With Sickle Cell Disease Who Have No Alternative Treatment Options Voxelotor - Sickle Cell Disease | | No longer available | | | 2024-11-20 |
Expanded Access to Voxelotor for Patients With Sickle Cell Disease Who Have No Alternative Treatment Options Voxelotor - Sickle Cell Disease | | No longer available | | | 2023-07-18 |
Conditions studied
Anemia, Sickle Cell (11) · Hypoxia (2) · Idiopathic Pulmonary Fibrosis (2) · Renal Insufficiency (1)
Sponsors
Global Blood Therapeutics (9) · Pfizer (7)
Countries
United States (14) · United Kingdom (6) · Egypt (3) · Lebanon (3) · Canada (2) · France (2) · Italy (2) · Kenya (2) · Netherlands (2) · Oman (2) · Turkey (Türkiye) (2) · Brazil (1) · Jamaica (1) · Nigeria (1)
Top investigators
Carla Washington, PhD (3) · Josh Lehrer-Graiwer, MD (2) · Carla Washington (1) · Ganesh Balaratnam, MBChB, BAO (1) · Timothy Mant, FRCP FFPM (1) · Timothy Mant, FRCP, FFPM (1)
Results publications
PMID 30655275, PMID 28337324, PMID 31199090, PMID 33476432, PMID 33838113
NIH funding
2014 (1), 2019 (1)