rHSA / Protgen - LARVOL DELTA

A randomized, double-blind, active-controlled phase 3 multicenter trial of rHSA for cirrhotic ascites. (PubMed, Signal Transduct Target Ther) - P2/3 | "Corroborated by LC‒MS characterization, silver-staining purity assessment, and four biochemical quality attributes (free thiol, Hcy, AGEs, and carbonyl levels), this divergence highlights the preserved molecular integrity of rHSA. This trial demonstrated that in patients with cirrhotic ascites, rHSA was statistically equivalent to pHSA in elevating serum ALB and non-inferior in ascites improvement, with a favorable safety profile."

Clinical • Journal • P3 data

Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical Trials (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Protgen Ltd | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Apr 2026 | Trial primary completion date: Dec 2026 ➔ Apr 2026

Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical Trials (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Protgen Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites (clinicaltrials.gov) - P2/3 | N=390 | Completed | Sponsor: Protgen Ltd | Not yet recruiting ➔ Completed | Trial primary completion date: Jan 2025 ➔ May 2025

Trial completion • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

To evaluate the safety and preliminary efficacy of recombinant human serum albumin injection in the treatment of mild to moderate Alzheimer's disease (ChiCTR) - P=N/A | N=30 | Recruiting | Sponsor: Shanghai Mental Health Center,; Shenzhen Protgen Ltd.

New trial • Alzheimer's Disease • CNS Disorders

A randomized, double-blind, parallel grouping phase II/III clinical trial to evaluate the efficacy and safety of recombinant human serum albumin versus human serum albumin in patients with cirrhosis and ascites(Phase III) (ChiCTR) - P3 | N=388 | Not yet recruiting | Sponsor: Beijing Friendship Hospital, Capital Medical University; Shenzhen Protgen Ltd.

New P3 trial • Fibrosis • Hepatology • Immunology

Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites (clinicaltrials.gov) - P2/3 | N=388 | Not yet recruiting | Sponsor: Protgen Ltd

New P2/3 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis