CDSCO Panel Clears PURE & CURE's Sickle Cell Trial With Conditions On Sample Size, Sites

Hydroxyurea is a widely used therapy in sickle cell disease and works by increasing fetal hemoglobin levels, thereby reducing the frequency of vaso-occlusive crises, which are painful episodes caused by blockage of blood vessels due to sickled red blood cells.

Following a detailed review, the SEC recommended permission to proceed with the trial but asked the firm to incorporate two important changes to the study design. First, the sample size must be increased to 200 patients to enhance the statistical robustness of the findings. Second, the clinical trial sites should be selected from Chhattisgarh and Nagpur, regions with a high prevalence of sickle cell disease, ensuring relevant population representation.

“After detail deliberation, the Committee recommended to grant the permission to conduct clinical trial as per protocol presented with following changes: 1. The sample size should be increased to 200 patients 2. Recruit clinical trial sites from the Chhattisgarh and Nagpur areas where the disease is prevalent,” the SEC noted in its recommendation.