Phase Ib of Recombinant Human Albumin Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2020-10-25

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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active comparator：HumanAlbumin

Participants received HumanAlbumin 10g/d

Group Type ACTIVE_COMPARATOR

HumanAlbumin

Intervention Type DRUG

Participants will receive HumanAlbumin of intravenous infusion

Experimental:Recombinant Human Albumin Injection 10g

Participants received Recombinant Human Albumin Injection 10g/d

Group Type EXPERIMENTAL

Recombinant Human Albumin Injection

Intervention Type DRUG

Participants will receive Recombinant Human Albumin Injection of intravenous infusion

Experimental:Recombinant Human Albumin Injection 20g

Participants received Recombinant Human Albumin Injection 20g/d

Group Type EXPERIMENTAL

Recombinant Human Albumin Injection

Intervention Type DRUG

Participants will receive Recombinant Human Albumin Injection of intravenous infusion

Experimental:Recombinant Human Albumin Injection 30g

Participants received Recombinant Human Albumin Injection 30g/d

Group Type EXPERIMENTAL

Recombinant Human Albumin Injection

Intervention Type DRUG

Participants will receive Recombinant Human Albumin Injection of intravenous infusion

Interventions

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Recombinant Human Albumin Injection

Participants will receive Recombinant Human Albumin Injection of intravenous infusion

Intervention Type DRUG

HumanAlbumin

Participants will receive HumanAlbumin of intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Intravenous infusion of human albumin injection Intravenous infusion of recombinant human albumin injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No