Phase Ib of Recombinant Human Albumin Injection

Jilin University

Status and phase: Completed; Phase 1

Conditions: Ascites

Treatments: Drug: Recombinant Human Albumin Injection; Drug: HumanAlbumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04701697

ART-2019-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

active comparator：HumanAlbumin

Active Comparator group

Description:

Participants received HumanAlbumin 10g/d

Treatment:

Drug: HumanAlbumin

Experimental:Recombinant Human Albumin Injection 10g

Experimental group

Description:

Participants received Recombinant Human Albumin Injection 10g/d

Treatment:

Drug: Recombinant Human Albumin Injection

Experimental:Recombinant Human Albumin Injection 20g

Experimental group

Description:

Participants received Recombinant Human Albumin Injection 20g/d

Treatment:

Drug: Recombinant Human Albumin Injection

Experimental:Recombinant Human Albumin Injection 30g

Experimental group

Description:

Participants received Recombinant Human Albumin Injection 30g/d

Treatment:

Drug: Recombinant Human Albumin Injection