Phase Ib of Recombinant Human Albumin Injection

Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis

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

Study Overview

• Status: Completed
• Conditions: Ascites
• Intervention / Treatment: Drug: HumanAlbumin; Drug: Recombinant Human Albumin Injection

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active comparator：HumanAlbumin; Participants received HumanAlbumin 10g/d	Drug: HumanAlbumin; Participants will receive HumanAlbumin of intravenous infusion; Other Names: Intravenous infusion of recombinant human albumin injection
Experimental: Experimental:Recombinant Human Albumin Injection 10g; Participants received Recombinant Human Albumin Injection 10g/d	Drug: Recombinant Human Albumin Injection; Participants will receive Recombinant Human Albumin Injection of intravenous infusion; Other Names: Intravenous infusion of human albumin injection
Experimental: Experimental:Recombinant Human Albumin Injection 20g; Participants received Recombinant Human Albumin Injection 20g/d	Drug: Recombinant Human Albumin Injection; Participants will receive Recombinant Human Albumin Injection of intravenous infusion; Other Names: Intravenous infusion of human albumin injection
Experimental: Experimental:Recombinant Human Albumin Injection 30g; Participants received Recombinant Human Albumin Injection 30g/d	Drug: Recombinant Human Albumin Injection; Participants will receive Recombinant Human Albumin Injection of intravenous infusion; Other Names: Intravenous infusion of human albumin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerance	Incidence and severity of adverse events	Day 1-Day 14（approximately，After the treatment）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major efficacy character: Albumin concentration change	Albumin concentration change from baseline to Day 14（approximately，After the treatment）	Day 1-Day 14（approximately，After the treatment）
Efficacy：Ascites regression rate	Ascites regression rate from baseline at Day 14（approximately，After the treatment）	Day 1-Day 14（approximately，After the treatment）
Efficacy：Ascites resolution time	Ascites resolution time	Day 1-Day 14（approximately，After the treatment）
Efficacy： HRS (hepato-renal syndrom)	Incidence of HRS	Day 1-Day 14（approximately，After the treatment）
Efficacy： OHE(overt hepatic encephalopathy)	Incidence of OHE	Day 1-Day 14（approximately，After the treatment）
Efficacy： abdominal circumference	Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）	Day 1-Day 14（approximately，After the treatment）
Efficacy：Weight	Change of Weight from baseline at Day 14（approximately，After the treatment）	Day 1-Day 14（approximately，After the treatment）
Pharmacodynamic parameters	Plasma colloidal osmotic pressure change from baseline	Day 1-Day 29
PK parameters	Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur	Day 1-Day 29
PK parameters	Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur	Day 1-Day 29
PK parameters	Half life (t1/2）as Recombinant Human Albumin administration occur	Day 1-Day 29
PK parameters	Area under the curve(AUC) as Recombinant Human Albumin administration occur	Day 1-Day 29
Immunogenicity	Percentage of patients with positive reaction against human albumin	Day 1-Day 29

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): October 25, 2020

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ascites
• Other Study ID Numbers: ART-2019-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No