drugset / Trial / NCT06911554
A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites
Phase 3
Completed
416 enrolled
Tonghua Anrate Biopharmaceutical Co., Ltd.
The First Hospital of Jilin University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.
Timeline
- Start
- 2023-06-16
- Primary completion
- 2024-09-27
- Completion
- 2024-09-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Albumin | Protein / enzyme biologic | 20 g | — |
| Subject | Recombinant Human Albumin | Protein / enzyme biologic | 20 g | — |
Indications
No indication recorded.