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

Hepatitis B Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294798
• Other study ID #: 9216-Ib
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 13, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2021
• Source: Tianjin SinoBiotech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus

Intervention

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.
• Pegasys
In comparator group, each subject will recieve 180mcg once per week.

Locations

Country	Name	City	State
China	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin SinoBiotech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rates of subjects with the level of HBVDNA=0 IU/mL after treatment	HBV DNA	17 weeks
Secondary	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
Secondary	the recovery rates of ALT after treatment	ALT	17 weeks
Secondary	the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment	HBsAg/HBeAg	17 weeks
Secondary	the rates of HBsAg decrease from baseline after treatment	HBsAg	17 weeks