Back to resultsEvaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis b
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
STSG-0002 Injection
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis b
Eligibility Criteria
Inclusion Criteria: Patients with chronic HBV； Receiving anti-HB viral therapy； 10 IU/ml≤HBsAg≤3000 IU/ml. Exclusion Criteria: Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV; Liver cirrhosis; Hepatocellular carcinoma; Autoimmune liver disease; Clinical hepatic decompensation; Fibroscan>12 kPa; a. hemoglobin<110g/L（female）<120 g/L（male），platelet<ULN，white blood cell<2.5×109/L；b. bilirubin>1.5 ×ULN，ALT>2 × ULN，serum albumin<35 g/L；c. INR>1.5；d. serum creatinine >1.5×ULN.
Sites / Locations
- Peking University First HospitalRecruiting
- Peking University People's Hospital
- Beijing Youan Hospital,Capital Medical
- The Second Affiliated Hospital of Chongqing Medical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
lowest dose treatment group
low dose treatment group
Intermediate dose treatment group
A single high dose of treatment group
Arm Description
Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements
Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements
Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements
Outcomes
Primary Outcome Measures
Number of subjects of adverse events
Number of subjects With Significant Abnormal Physical Examination
Number of subjects of Significant Abnormal Vital Signs Findings
Number of Participants With Significant Abnormal Laboratory Values
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Secondary Outcome Measures
Full Information
NCT ID
NCT05760703
First Posted
February 23, 2023
Last Updated
May 15, 2023
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Collaborators
Beijing Sanuo Jiayi Biotechnology Co. LTD
1. Study Identification
Unique Protocol Identification Number
NCT05760703
Brief Title
Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Official Title
Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy(Long-term Follow-up)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Collaborators
Beijing Sanuo Jiayi Biotechnology Co. LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy(Long-term follow-up).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lowest dose treatment group
Arm Type
Experimental
Arm Description
Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements
Arm Title
low dose treatment group
Arm Type
Experimental
Arm Description
Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements
Arm Title
Intermediate dose treatment group
Arm Type
Experimental
Arm Description
Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
Arm Title
A single high dose of treatment group
Arm Type
Experimental
Arm Description
Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements
Intervention Type
Drug
Intervention Name(s)
STSG-0002 Injection
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Number of subjects of adverse events
Time Frame
Baseline to Day 180
Title
Number of subjects With Significant Abnormal Physical Examination
Time Frame
Baseline to Day 180
Title
Number of subjects of Significant Abnormal Vital Signs Findings
Time Frame
Baseline to Day 180
Title
Number of Participants With Significant Abnormal Laboratory Values
Time Frame
Baseline to Day 180
Title
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time Frame
Baseline to Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic HBV；
Receiving anti-HB viral therapy；
10 IU/ml≤HBsAg≤3000 IU/ml.
Exclusion Criteria:
Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;
Liver cirrhosis;
Hepatocellular carcinoma;
Autoimmune liver disease;
Clinical hepatic decompensation;
Fibroscan>12 kPa;
a. hemoglobin<110g/L（female）<120 g/L（male），platelet<ULN，white blood cell<2.5×109/L；b. bilirubin>1.5 ×ULN，ALT>2 × ULN，serum albumin<35 g/L；c. INR>1.5；d. serum creatinine >1.5×ULN.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Liu
Phone
+86 18519789088
Email
liumin@staidson.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Phone
+8613911405123
Email
john131212@sina.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Feng
Phone
+8613810254109
Email
fengbo@pkuph.edu.cn
Facility Name
Beijing Youan Hospital,Capital Medical
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujun Zheng
Phone
+8615810716239
Email
zhengsujun003@126.com
Facility Name
The Second Affiliated Hospital of Chongqing Medical
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
401437
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Ren
Phone
+8613983888786
Email
renhong0531@vip.sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
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