Clinical trial NCT03294798: Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis B Virus
Lead sponsor: Tianjin SinoBiotech Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
timeFrame: 17 weeks
Secondary outcomes:
measure: the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment
timeFrame: 4 weeks and 17 weeks
measure: the recovery rates of ALT after treatment
timeFrame: 17 weeks
measure: the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
timeFrame: 17 weeks
measure: the rates of HBsAg decrease from baseline after treatment
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing YouAn Hospital
name: meixia wang, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: jun li, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Public Health Clinical Center
name: liang chen, professor
role: PRINCIPAL_INVESTIGATOR
References: