Ascites Clinical Trial - Phase Ib of Recombinant Human Albumin Injection

Status Completed

Clinical Trial Summary

A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis

Clinical Trial Description

This study was to evaluate the safety, tolerability,efficacy, pharmacokinetics and immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis. The study design consists of two phases: Screening and treatment phase(dose increasing stage).Following the Screening phase, all eligible subjects will be randomized to receive recombinant human albumin injection or HumanAlbumin, study medication in a 3:1 ratio.Dose increasing stage (including 3 dose groups with increasing dose, and each group was set with HumanAlbumin control).The initial dose was 10g. The highest dose group was set at 30g. ;

Study Design

Related Conditions & MeSH terms

Ascites

Clinical Trial Details

NCT number	NCT04701697
Study type	Interventional
Source	First Hospital of Jilin University
Contact
Status	Completed
Phase	Phase 1
Start date	March 15, 2020
Completion date	October 25, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02891642` - Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Recruiting	`NCT00239096` - Prevention of Decompensation in Liver Cirrhosis	Phase 4
Active, not recruiting	`NCT03973866` - Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)	N/A
Completed	`NCT01349348` - Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites	Phase 3
Terminated	`NCT01455246` - Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis	Phase 2/Phase 3
Completed	`NCT01578226` - Procalcitonin in Cirrhotic Patients at High Risk for Sepsis	N/A
Terminated	`NCT00548366` - Sodium Restriction in the Management of Cirrhotic Ascites	Phase 4
Recruiting	`NCT05025878` - 13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
Completed	`NCT03327688` - Point-of-care Ultrasound in Finland	N/A
Not yet recruiting	`NCT04550091` - Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites
Completed	`NCT01769040` - Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis	Phase 4
Not yet recruiting	`NCT01716611` - Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites	Phase 4
Recruiting	`NCT05700708` - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Recruiting	`NCT05511766` - Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis	Phase 2/Phase 3
Completed	`NCT05013502` - Empagliflozin in Diuretic Refractory Ascites	Phase 1
Not yet recruiting	`NCT06436807` - PMCF Study of the CE-marked Drainova® ArgentiC Catheter
Completed	`NCT03263598` - Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites
Completed	`NCT00907673` - The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure	N/A
Suspended	`NCT00511394` - Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis	N/A
Terminated	`NCT00796861` - Trial of Sunitinib for Refractory Malignant Ascites	Phase 2