Status:
COMPLETED
Phase Ib of Recombinant Human Albumin Injection
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Ascites
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 injecti...
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 o...
Eligibility Criteria
Inclusion
- 18-75 years of age;
- No less than 45 kg.
- Diagnosed with ascites due to cirrhosis.
Exclusion
- Allergy to biological products;
- West-Haven HE ≥ III ;
- Uncontrolled severe infections;
- HRS. Serum creatinine (Cr)\>2×ULN, or Cr increase\>50% during the screening period;
- Combined with other serious underlying diseases.
- Organ transplant recipients;
- 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:
- PLT\<30×109/L, HGB\<70 g/L;
- ALT and (or) AST\> 5×ULN, TBIL\>3×ULN;
- Prothrombin activity \<40%, PT prolonged\>5s;
- LVEF \<50%;
- The 24h urine volume exceeds 1500 mL/day ;
- 10\) Other subjects by investigator's opinion.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04701697
Start Date
March 15 2020
End Date
October 25 2020
Last Update
January 8 2021
Active Locations (1)
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1
the first hospital of Jilin University
Changchun, Jilin, China, 130021