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Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites

NCT06553456 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-03-10

No results posted yet for this study

Summary

This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.

Conditions

  • Cirrhotic Ascites

Interventions

DRUG

Recombinant Human Serum Albumin

The experimental drug was administered at a dose of 20 g/ day for 7 days.

DRUG

Human Serum Albumin

The positive control drug was administered at a dose of 20 g/ day for 7 days.

Sponsors & Collaborators

  • Protgen Ltd

    lead INDUSTRY

Principal Investigators

  • Jidong Jia, Ph.D · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2025-05-14
Completion
2025-05-14

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 NCT06553456 on ClinicalTrials.gov