Phase Ib of Recombinant Human Albumin Injection

• Status: Completed
• Trial end date: 2020-10-25
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Hospital of Jilin University; The First Hospital of Jilin University

Criteria

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.