- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05760781
To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
December 13, 2023 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100044
- Peking University People's Hospital
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Beijing, Beijing, China, 100032
- Peking University First Hospital
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Beijing, Beijing, China, 100069
- Beijing Youan Hospital,Capital Medical
-
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Chongqing
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Chongqing, Chongqing, China, 401437
- The Second Affiliated Hospital of Chongqing Medical
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lowest dose treatment group
Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements
|
Intravenous infusion
|
Experimental: low dose treatment group
Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements
|
Intravenous infusion
|
Experimental: Intermediate dose treatment group
Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
|
Intravenous infusion
|
Experimental: A single high dose of treatment group
Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements
|
Intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects of adverse events
Time Frame: Baseline to Day 180
|
Baseline to Day 180
|
Number of subjects With Significant Abnormal Physical Examination
Time Frame: Baseline to Day 180
|
Baseline to Day 180
|
Number of subjects of Significant Abnormal Vital Signs Findings
Time Frame: Baseline to Day 180
|
Baseline to Day 180
|
Number of Participants With Significant Abnormal Laboratory Values
Time Frame: Baseline to Day 180
|
Baseline to Day 180
|
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time Frame: Baseline to Day 180
|
Baseline to Day 180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Guiqiang Wang, Peking University First Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2023
Primary Completion (Actual)
December 11, 2023
Study Completion (Actual)
December 11, 2023
Study Registration Dates
First Submitted
February 23, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 8, 2023
Study Record Updates
Last Update Posted (Actual)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Chronic Disease
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- STS-STSG0002-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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