CDSCO Panel Asks Shilpa Biologicals to Revise Phase III Protocol for Recombinant Human Serum Albumin Study
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has sought major revisions in the Phase III clinical trial protocol submitted by Shilpa Biologicals Private Limited for its Recombinant Human Serum Albumin (rHSA) 20% formulation.
This came after the firm presented phase III clinical study Protocol No.: RHSA/SBPL/P3/AB2025 Version No. 01 dated 21-JUL-2025.
Recombinant human serum albumin (rHSA) 20% is a highly pure, animal-origin-free protein solution produced using recombinant DNA technology, which eliminates the risk of transmitting infectious agents found in human plasma-derived products. It is available as a clear, slightly viscous liquid for various applications.
At the recent SEC meeting for gastroenterology and Hepatology, the expert panel reviewed the phase III clinical study Protocol No.: RHSA/SBPL/P3/AB2025 Version No. 01 dated 21-JUL-2025, for Recombinant Human Serum Albumin (rHSA) 20%.
After detailed deliberation, the committee opined that the firm shall submit the following for further review by the committee.
1. The study protocol shall include clinical endpoint as primary outcome and also include safety evaluation as secondary outcome
2. The Primary objective shall include the change of serum albumin concentration after transfusion of 100 gm of albumin solution.
3. Secondary endpoints shall address the reduction of ascites and changes in body weight analysis should be standardized based on diuretic dose calculation.
4. The serum Albumin level is to be correlated with Serum calcium level obtained from the sample.
