Phase Ib of Recombinant Human Albumin Injection

Phase 1

Completed

• Conditions: Ascites
• Interventions: Drug: HumanAlbumin; Drug: Recombinant Human Albumin Injection

• Registration Number: NCT04701697
• Lead Sponsor: The First Hospital of Jilin University

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 injection in Patients With Hepatic Cirrhosis

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 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.

Study Timeline

• Study Start: 2020-03-15
• Primary Completion: 2020-09-10
• Study Completion: 2020-10-25
• Status Verified: 2020-11
• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active comparator：HumanAlbumin	HumanAlbumin	Participants received HumanAlbumin 10g/d
Experimental:Recombinant Human Albumin Injection 10g	Recombinant Human Albumin Injection	Participants received Recombinant Human Albumin Injection 10g/d
Experimental:Recombinant Human Albumin Injection 20g	Recombinant Human Albumin Injection	Participants received Recombinant Human Albumin Injection 20g/d
Experimental:Recombinant Human Albumin Injection 30g	Recombinant Human Albumin Injection	Participants received Recombinant Human Albumin Injection 30g/d

Primary Outcome Measures

Name	Time	Method
Safety and tolerance	Day 1-Day 14（approximately，After the treatment）	Incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Major efficacy character: Albumin concentration change	Day 1-Day 14（approximately，After the treatment）	Albumin concentration change from baseline to Day 14（approximately，After the treatment）
Efficacy：Ascites regression rate	Day 1-Day 14（approximately，After the treatment）	Ascites regression rate from baseline at Day 14（approximately，After the treatment）
Efficacy：Ascites resolution time	Day 1-Day 14（approximately，After the treatment）	Ascites resolution time
Efficacy： HRS (hepato-renal syndrom)	Day 1-Day 14（approximately，After the treatment）	Incidence of HRS
Efficacy：Weight	Day 1-Day 14（approximately，After the treatment）	Change of Weight from baseline at Day 14（approximately，After the treatment）
Immunogenicity	Day 1-Day 29	Percentage of patients with positive reaction against human albumin
Efficacy： OHE(overt hepatic encephalopathy)	Day 1-Day 14（approximately，After the treatment）	Incidence of OHE
Efficacy： abdominal circumference	Day 1-Day 14（approximately，After the treatment）	Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）
Pharmacodynamic parameters	Day 1-Day 29	Plasma colloidal osmotic pressure change from baseline
PK parameters	Day 1-Day 29	Area under the curve(AUC) as Recombinant Human Albumin administration occur

Trial Locations

Locations (1)

the first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China