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

Phase 1

Completed

• Conditions: Hepatitis B Virus
• Interventions: Biological: Human Serum Albumin/interferon alpha2b fusion protein; Biological: Pegasys

• Registration Number: NCT03294798
• Lead Sponsor: Tianjin SinoBiotech Ltd.

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.

Study Timeline

• Study Start: 2017-06-13
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-27
• Primary Completion: 2019-03-15
• Status Verified: 2021-03
• Study Completion: 2021-03-15
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Serum Albumin/interferon alpha2b	Human Serum Albumin/interferon alpha2b fusion protein	Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.
Pegasys	Pegasys	Pegasys 180 mcg, once per week

Primary Outcome Measures

Name	Time	Method
the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment	17 weeks	HBV DNA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing YouAn Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China