Status:
COMPLETED
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
Lead Sponsor:
Tianjin SinoBiotech Ltd.
Conditions:
Hepatitis B Virus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 ...
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 Prote...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03294798
Start Date
June 13 2017
End Date
March 15 2021
Last Update
April 1 2021
Active Locations (1)
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1
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069