drugset / Trial / NCT02268409
Extension Study to Evaluate the Safety and Efficacy of Luspatercept in Participants With β-Thalassemia Previously Enrolled in A536-04 (A536-06/MK-6143-004)
NaSingle-groupOpen-labelTreatment
Summary
Study A536-06 (MK-6143-004) is an open-label extension study for participants previously enrolled in study A536-04 (NCT01749540), to evaluate the long-term safety and tolerability of luspatercept in adult participants with beta-thalassemia.
Timeline
- Start
- 2014-10-20
- Primary completion
- 2020-06-18
- Completion
- 2020-06-18
Publications
- Piga A, Longo F, Gamberini MR, Voskaridou E, Ricchi P, Caruso V, Pietrangelo A, Zhang X, Shetty JK, Attie KM, Tartaglione I. Long-term safety and erythroid response with luspatercept treatment in patients with beta-thalassemia. Ther Adv Hematol. 2022 Dec 5;13:20406207221134404. doi: 10.1177/20406207221134404. eCollection 2022.
- Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, Caruso V, Pietrangelo A, Longo F, Tartaglione I, Borgna-Pignatti C, Zhang X, Laadem A, Sherman ML, Attie KM. Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with beta-thalassemia. Blood. 2019 Mar 21;133(12):1279-1289. doi: 10.1182/blood-2018-10-879247. Epub 2019 Jan 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luspatercept | Protein / enzyme biologic | 0.6 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 0.8 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1.25 mg/kg | Subcutaneous |