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

NCT ID: NCT03294798

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2021-03-15

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.

Conditions

Hepatitis B Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Serum Albumin/interferon alpha2b

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

Group Type: EXPERIMENTAL

Human Serum Albumin/interferon alpha2b fusion protein

Intervention Type: BIOLOGICAL

In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.

Pegasys

Pegasys 180 mcg, once per week

Group Type: ACTIVE_COMPARATOR

Pegasys

Intervention Type: BIOLOGICAL

In comparator group, each subject will recieve 180mcg once per week.

Interventions

Human Serum Albumin/interferon alpha2b fusion protein

In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.

Intervention Type: BIOLOGICAL

Pegasys

In comparator group, each subject will recieve 180mcg once per week.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin SinoBiotech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

meixia wang, professor

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

jun li, professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

liang chen, professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Public Health Clinical Center

Locations

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

9216-Ib

Identifier Type: -

Identifier Source: org_study_id