Clinical trial NCT04701697: Phase Ib of Recombinant Human Albumin Injection
Official title: Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ascites
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerance
timeFrame: Day 1-Day 14（approximately，After the treatment）
Secondary outcomes:
measure: Major efficacy character: Albumin concentration change
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Efficacy：Ascites regression rate
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Efficacy：Ascites resolution time
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Efficacy： HRS (hepato-renal syndrom)
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Efficacy： OHE(overt hepatic encephalopathy)
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Efficacy： abdominal circumference
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Efficacy：Weight
timeFrame: Day 1-Day 14（approximately，After the treatment）
measure: Pharmacodynamic parameters
timeFrame: Day 1-Day 29
measure: PK parameters
timeFrame: Day 1-Day 29
measure: PK parameters
timeFrame: Day 1-Day 29
measure: PK parameters
timeFrame: Day 1-Day 29
measure: PK parameters
timeFrame: Day 1-Day 29
measure: Immunogenicity
timeFrame: Day 1-Day 29
Other outcomes:
Locations:
city: Changchun
country: China
facility: the first hospital of Jilin University
state: Jilin
Study officials:
affiliation: The first affiliated hospital of Jilin University
name: Junqi Niu, Dr
role: STUDY_DIRECTOR
References: