Ascites
Conditions
Brief 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
Detailed 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.
Interventions
Participants will receive Recombinant Human Albumin Injection of intravenous infusion
DRUGHumanAlbumin
Participants will receive HumanAlbumin of intravenous infusion
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18-75 years of age; 2. No less than 45 kg. 3. Diagnosed with ascites due to cirrhosis.
Exclusion criteria
1. Allergy to biological products; 2. West-Haven HE ≥ III ; 3. Uncontrolled severe infections; 4. HRS. Serum creatinine (Cr)\>2×ULN, or Cr increase\>50% during the screening period; 5. Combined with other serious underlying diseases. 6. Organ transplant recipients; 7. 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: 1. PLT\<30×109/L, HGB\<70 g/L; 2. ALT and (or) AST\> 5×ULN, TBIL\>3×ULN; 3. Prothrombin activity \<40%, PT prolonged\>5s; 4. LVEF \<50%; 5. The 24h urine volume exceeds 1500 mL/day ; 10\) Other subjects by investigator's opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerance | Day 1-Day 14（approximately，After the treatment） | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major efficacy character: Albumin concentration change | Day 1-Day 14（approximately，After the treatment） | Albumin concentration change from baseline to Day 14（approximately，After the treatment） |
| Efficacy：Ascites regression rate | Day 1-Day 14（approximately，After the treatment） | Ascites regression rate from baseline at Day 14（approximately，After the treatment） |
| Efficacy：Ascites resolution time | Day 1-Day 14（approximately，After the treatment） | Ascites resolution time |
| Efficacy： HRS (hepato-renal syndrom) | Day 1-Day 14（approximately，After the treatment） | Incidence of HRS |
| Efficacy： OHE(overt hepatic encephalopathy) | Day 1-Day 14（approximately，After the treatment） | Incidence of OHE |
| Efficacy：Weight | Day 1-Day 14（approximately，After the treatment） | Change of Weight from baseline at Day 14（approximately，After the treatment） |
| Pharmacodynamic parameters | Day 1-Day 29 | Plasma colloidal osmotic pressure change from baseline |
| PK parameters | Day 1-Day 29 | Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur |
| Immunogenicity | Day 1-Day 29 | Percentage of patients with positive reaction against human albumin |
| Efficacy： abdominal circumference | Day 1-Day 14（approximately，After the treatment） | Change of abdominal circumference from baseline at Day 14（approximately，After the treatment） |
Countries
China
Outcome results
None listed