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

Tianjin SinoBiotech

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis B Virus

Treatments

Biological: Human Serum Albumin/interferon alpha2b fusion protein

Biological: Pegasys

Study type

Interventional

Funder types

Industry

Identifiers

NCT03294798

9216-Ib

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.