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Phase II/III of Recombinant Human Albumin Injection

NCT06411743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-13

No results posted yet for this study

Summary

This study was a Phase II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and to provide a reference for the design of the Phase III clinical study.

Conditions

  • Hepatic Ascites

Interventions

BIOLOGICAL

Recombinant Human Albumin Injection

Recombinant Human Albumin injection, strength: 10 g/vial (20%, 50 mL); storage conditions: 2-8°C, protected from light; manufactured and supplied by Tonghua Anrate Biopharmaceutical Co., Ltd.

BIOLOGICAL

Human Albumin

Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS Blood Products Co., Ltd.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Junqi Junqi · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2022-08-15
Completion
2022-08-15

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 NCT06411743 on ClinicalTrials.gov