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

Sponsor

Tianjin SinoBiotech Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03294798

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Virus	Biological: Human Serum Albumin/interferon alpha2b fusion protein Biological: Pegasys	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 13, 2017

Actual Primary Completion Date :

Mar 15, 2019

Actual Study Completion Date :

Mar 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment [17 weeks]
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing	China	100069

Sponsors and Collaborators

Tianjin SinoBiotech Ltd.

Investigators

Principal Investigator: meixia wang, professor, Beijing YouAn Hospital
Principal Investigator: jun li, professor, The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: liang chen, professor, Shanghai Public Health Clinical Center