drugset / Trial / NCT05249374
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.
Timeline
- Start
- 2021-10-14
- Primary completion
- 2022-05-16
- Completion
- 2022-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED | Protein / enzyme biologic | 10 g | Intravenous |
| Comparator | HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED | Protein / enzyme biologic | 20 g | Intravenous |
| Comparator | HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED | Protein / enzyme biologic | 30 g | Intravenous |
| Subject | Human serum albumin | Protein / enzyme biologic | 10 g | Intravenous |
Indications
No indication recorded.