Phase Ib of Recombinant Human Albumin Injection

Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701697
• Other study ID #: ART-2019-002
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2020
• Est. completion date: October 25, 2020

Study information

• Verified date: November 2020
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 25, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ascites

Intervention

Drug:
• Recombinant Human Albumin Injection
Participants will receive Recombinant Human Albumin Injection of intravenous infusion
• HumanAlbumin
Participants will receive HumanAlbumin of intravenous infusion

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

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