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Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

NCT05249374 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Hepatic Ascites

Interventions

DRUG

Recombinant Human Serum Albumin

10 g/bottle (20%, 50 mL)

DRUG

Human serum albumin

10 g/bottle (20%, 50 mL)

Sponsors & Collaborators

  • Protgen Ltd

    lead INDUSTRY

Principal Investigators

  • Rui Chen, Ph.D · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2022-05-16
Completion
2022-05-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05249374 on ClinicalTrials.gov