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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B Virus
• Intervention / Treatment: Biological: Human Serum Albumin/interferon alpha2b fusion protein; Biological: Pegasys

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Beijing Youan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Serum Albumin/interferon alpha2b; Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.	Biological: 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.
Active Comparator: Pegasys; Pegasys 180 mcg, once per week	Biological: Pegasys; In comparator group, each subject will recieve 180mcg once per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment	HBV DNA	17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment	HBV DNA	4 weeks and 17 weeks
the recovery rates of ALT after treatment	ALT	17 weeks
the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment	HBsAg/HBeAg	17 weeks
the rates of HBsAg decrease from baseline after treatment	HBsAg	17 weeks

Collaborators and Investigators

• Sponsor: Tianjin SinoBiotech Ltd.
• Investigators: Principal Investigator: jun li, professor, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: liang chen, professor, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Peginterferon alfa-2a; Interferon alpha-2
• Other Study ID Numbers: 9216-Ib

Drug and device information, study documents

• 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