Intas Pharmaceutical Gets CDSCO Panel Nod To Conduct Phase III clinical trial of Fibrogen-I
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of Fibrogen-I (Human Fibrinogen Injection) for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in patients with congenital fibrinogen deficiency.
This came after Intas Pharmaceuticals presented the proposal to conduct phase III Clinical trial titled: “A Single Group, Non-Randomized, Multicenter, Interventional Phase-3 Study to Investigate Efficacy, Safety and Pharmacokinetics of Fibrogen-I (Human Fibrinogen Injection) for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Patients with Congenital Fibrinogen Deficiency” vide Protocol No. 0394-23 Version: 1.0 Dated 10.07.2024.
Human fibrinogen is a soluble plasma glycoprotein, synthesized in the liver, that plays a crucial role in blood clotting by converting to fibrin, the main protein in blood clots, to stop bleeding and facilitate wound healing.
Fibrinogen is a protein found in the blood plasma, and it's the precursor to fibrin, the protein that forms the meshwork of blood clots. When a blood vessel is damaged, fibrinogen is converted into fibrin by the enzyme thrombin. Fibrin forms a mesh-like network that traps blood cells and platelets, creating a clot that stops bleeding. The clot helps to seal the wound and provides a scaffold for tissue repair.
At the recent SEC meeting for Hematology , the expert panel reviewed the proposal to conduct phase III clinical trial titled :“A Single Group, Non-Randomized, Multicenter, Interventional Phase-3 Study to Investigate Efficacy, Safety and Pharmacokinetics of Fibrogen-I TM(Human Fibrinogen Injection) for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Patients with Congenital Fibrinogen Deficiency”.
After detailed deliberation, the committee recommended granting permission to conduct Phase III CT as per the applied protocol.
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