Phase Ib of Recombinant Human Albumin Injection

January 6, 2021 updated by: The First Hospital of Jilin University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerance
Time Frame: Day 1-Day 14（approximately，After the treatment）
Incidence and severity of adverse events
Day 1-Day 14（approximately，After the treatment）

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major efficacy character: Albumin concentration change
Time Frame: Day 1-Day 14（approximately，After the treatment）
Albumin concentration change from baseline to Day 14（approximately，After the treatment）
Day 1-Day 14（approximately，After the treatment）
Efficacy：Ascites regression rate
Time Frame: Day 1-Day 14（approximately，After the treatment）
Ascites regression rate from baseline at Day 14（approximately，After the treatment）
Day 1-Day 14（approximately，After the treatment）
Efficacy：Ascites resolution time
Time Frame: Day 1-Day 14（approximately，After the treatment）
Ascites resolution time
Day 1-Day 14（approximately，After the treatment）
Efficacy： HRS (hepato-renal syndrom)
Time Frame: Day 1-Day 14（approximately，After the treatment）
Incidence of HRS
Day 1-Day 14（approximately，After the treatment）
Efficacy： OHE(overt hepatic encephalopathy)
Time Frame: Day 1-Day 14（approximately，After the treatment）
Incidence of OHE
Day 1-Day 14（approximately，After the treatment）
Efficacy： abdominal circumference
Time Frame: Day 1-Day 14（approximately，After the treatment）
Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）
Day 1-Day 14（approximately，After the treatment）
Efficacy：Weight
Time Frame: Day 1-Day 14（approximately，After the treatment）
Change of Weight from baseline at Day 14（approximately，After the treatment）
Day 1-Day 14（approximately，After the treatment）
Pharmacodynamic parameters
Time Frame: Day 1-Day 29
Plasma colloidal osmotic pressure change from baseline
Day 1-Day 29
PK parameters
Time Frame: Day 1-Day 29
Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur
Day 1-Day 29
PK parameters
Time Frame: Day 1-Day 29
Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur
Day 1-Day 29
PK parameters
Time Frame: Day 1-Day 29
Half life (t1/2）as Recombinant Human Albumin administration occur
Day 1-Day 29
PK parameters
Time Frame: Day 1-Day 29
Area under the curve(AUC) as Recombinant Human Albumin administration occur
Day 1-Day 29
Immunogenicity
Time Frame: Day 1-Day 29
Percentage of patients with positive reaction against human albumin
Day 1-Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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