A Phase 1 interventional study of Recombinant Human Albumin Injection and HumanAlbumin in Ascites, sponsored by The First Hospital of Jilin University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by The First Hospital of Jilin University · Phase 1, Interventional, and Treatment
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
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.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's enrollment of 36 is below the median of 55 across 177 interventional studies indexed under Ascites.
Browse Ascites studies →The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Child-bearing females. Pregnancy test positive. Refusing to take contraceptive measures; (8) Participation in other clinical trials. Using study drugs within three month; (9) With the following laboratory test abnormality:
Participants received HumanAlbumin 10g/d
Drug: HumanAlbumin
Participants received Recombinant Human Albumin Injection 10g/d
Drug: Recombinant Human Albumin Injection
Participants received Recombinant Human Albumin Injection 20g/d
Drug: Recombinant Human Albumin Injection
Participants received Recombinant Human Albumin Injection 30g/d
Drug: Recombinant Human Albumin Injection
Participants will receive Recombinant Human Albumin Injection of intravenous infusion
Also known as: Intravenous infusion of human albumin injection
Participants will receive HumanAlbumin of intravenous infusion
Also known as: Intravenous infusion of recombinant human albumin injection
Safety and tolerance
Incidence and severity of adverse events
Time frame: Day 1-Day 14（approximately，After the treatment）
Major efficacy character: Albumin concentration change
Albumin concentration change from baseline to Day 14（approximately，After the treatment）
Time frame: Day 1-Day 14（approximately，After the treatment）
Efficacy：Ascites regression rate
Ascites regression rate from baseline at Day 14（approximately，After the treatment）
Time frame: Day 1-Day 14（approximately，After the treatment）
Efficacy：Ascites resolution time
Ascites resolution time
Time frame: Day 1-Day 14（approximately，After the treatment）
Efficacy： HRS (hepato-renal syndrom)
Incidence of HRS
Time frame: Day 1-Day 14（approximately，After the treatment）
Efficacy： OHE(overt hepatic encephalopathy)
Incidence of OHE
Time frame: Day 1-Day 14（approximately，After the treatment）
Efficacy： abdominal circumference
Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）
Time frame: Day 1-Day 14（approximately，After the treatment）
Efficacy：Weight
Change of Weight from baseline at Day 14（approximately，After the treatment）
Time frame: Day 1-Day 14（approximately，After the treatment）
Pharmacodynamic parameters
Plasma colloidal osmotic pressure change from baseline
Time frame: Day 1-Day 29
PK parameters
Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur
Time frame: Day 1-Day 29
PK parameters
Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur
Time frame: Day 1-Day 29
PK parameters
Half life (t1/2）as Recombinant Human Albumin administration occur
Time frame: Day 1-Day 29
PK parameters
Area under the curve(AUC) as Recombinant Human Albumin administration occur
Time frame: Day 1-Day 29
Immunogenicity
Percentage of patients with positive reaction against human albumin
Time frame: Day 1-Day 29
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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The First Hospital of Jilin University