Phase Ib of Recombinant Human Albumin Injection

Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis

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.

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.