Phase Ib of Recombinant Human Albumin Injection
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: active comparator：HumanAlbumin Participants received HumanAlbumin 10g/d |
Drug: HumanAlbumin
Participants will receive HumanAlbumin of intravenous infusion
Other Names:
|
| 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:
|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerance [Day 1-Day 14（approximately，After the treatment）]
Incidence and severity of adverse events
Secondary Outcome Measures
- 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： 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）
- Efficacy：Weight [Day 1-Day 14（approximately，After the treatment）]
Change of Weight 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]
Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur
- PK parameters [Day 1-Day 29]
Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur
- PK parameters [Day 1-Day 29]
Half life (t1/2）as Recombinant Human Albumin administration occur
- PK parameters [Day 1-Day 29]
Area under the curve(AUC) as Recombinant Human Albumin administration occur
- Immunogenicity [Day 1-Day 29]
Percentage of patients with positive reaction against human albumin
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-75 years of age;
-
No less than 45 kg.
-
Diagnosed with ascites due to cirrhosis.
Exclusion Criteria:
-
Allergy to biological products;
-
West-Haven HE ≥ III ;
-
Uncontrolled severe infections;
-
HRS. Serum creatinine (Cr)>2×ULN, or Cr increase>50% during the screening period;
-
Combined with other serious underlying diseases.
-
Organ transplant recipients;
-
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:
-
PLT<30×109/L, HGB<70 g/L;
-
ALT and (or) AST> 5×ULN, TBIL>3×ULN;
-
Prothrombin activity <40%, PT prolonged>5s;
-
LVEF <50%;
-
The 24h urine volume exceeds 1500 mL/day ;
- Other subjects by investigator's opinion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the first hospital of Jilin University | Changchun | Jilin | China | 130021 |
Sponsors and Collaborators
- The First Hospital of Jilin University
Investigators
- Study Director: Junqi Niu, Dr, The first affiliated hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ART-2019-002