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Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient

Primary Purpose

Hepatitis B Virus

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human Serum Albumin/interferon alpha2b fusion protein
Pegasys
Sponsored by
Tianjin SinoBiotech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B Virus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HBV patients who have positive HBeAg or HBeAb
  • Must be healthy males or females between 18 to 60 years old
  • Must have a body mass index (BMI) of 18 to 30 kg/m2
  • HBV DNA≥2000 IU/mL
  • ALT≥1.3 ULN and ≤10 ULN

Exclusion Criteria:

  • Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time.
  • Participated in other clinical trials within a month.
  • Allergic to interferon.
  • T-Bil ≥2 ULN. ALB<35g/L. PT≥4s.
  • Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab.
  • Organ transplant patients, except cornea or hair transplantation.
  • Other hepatopathy exclude NAFLD .
  • Drug addiction or alcohol dependence.
  • Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history.
  • Serious retinal disease.
  • Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder.
  • Autoimmune disease.
  • Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure.
  • WBC<3×109/L or ANC<1.5 ×109/L or PLT<90 ×109/L or HGB<ULN.
  • HCC or AFP>100ng/mL.
  • Chronic kidney disease or sCr>ULN.
  • Lactating women or pregnancy.
  • Cardiovascular and cerebrovascular events within 6 months.
  • Neurological or psychiatric disease or family history.

Sites / Locations

  • Beijing YouAn Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Human Serum Albumin/interferon alpha2b

Pegasys

Arm Description

Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.

Pegasys 180 mcg, once per week

Outcomes

Primary Outcome Measures

the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
HBV DNA

Secondary Outcome Measures

the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment
HBV DNA
the recovery rates of ALT after treatment
ALT
the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
HBsAg/HBeAg
the rates of HBsAg decrease from baseline after treatment
HBsAg

Full Information

First Posted
September 21, 2017
Last Updated
March 29, 2021
Sponsor
Tianjin SinoBiotech Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03294798
Brief Title
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
Official Title
Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose & Multiple Dose by Using Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitits B Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin SinoBiotech Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
Detailed Description
This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human Serum Albumin/interferon alpha2b
Arm Type
Experimental
Arm Description
Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.
Arm Title
Pegasys
Arm Type
Active Comparator
Arm Description
Pegasys 180 mcg, once per week
Intervention Type
Biological
Intervention Name(s)
Human Serum Albumin/interferon alpha2b fusion protein
Intervention Description
In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
Intervention Type
Biological
Intervention Name(s)
Pegasys
Intervention Description
In comparator group, each subject will recieve 180mcg once per week.
Primary Outcome Measure Information:
Title
the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
Description
HBV DNA
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment
Description
HBV DNA
Time Frame
4 weeks and 17 weeks
Title
the recovery rates of ALT after treatment
Description
ALT
Time Frame
17 weeks
Title
the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
Description
HBsAg/HBeAg
Time Frame
17 weeks
Title
the rates of HBsAg decrease from baseline after treatment
Description
HBsAg
Time Frame
17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HBV patients who have positive HBeAg or HBeAb Must be healthy males or females between 18 to 60 years old Must have a body mass index (BMI) of 18 to 30 kg/m2 HBV DNA≥2000 IU/mL ALT≥1.3 ULN and ≤10 ULN Exclusion Criteria: Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time. Participated in other clinical trials within a month. Allergic to interferon. T-Bil ≥2 ULN. ALB<35g/L. PT≥4s. Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab. Organ transplant patients, except cornea or hair transplantation. Other hepatopathy exclude NAFLD . Drug addiction or alcohol dependence. Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history. Serious retinal disease. Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder. Autoimmune disease. Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure. WBC<3×109/L or ANC<1.5 ×109/L or PLT<90 ×109/L or HGB<ULN. HCC or AFP>100ng/mL. Chronic kidney disease or sCr>ULN. Lactating women or pregnancy. Cardiovascular and cerebrovascular events within 6 months. Neurological or psychiatric disease or family history.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
meixia wang, professor
Organizational Affiliation
Beijing YouAn Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
jun li, professor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
liang chen, professor
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing YouAn Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China

12. IPD Sharing Statement

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Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient

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