Chronic Hepatitis bPhase 2NCT05760781
To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
A Phase 2 study testing STSG-0002 Injection in people with Chronic Hepatitis b, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- STSG-0002 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesChina
- Study dates
- 25 Apr 2023to 11 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic HBV；
- Receiving anti-HB viral therapy;
- 10 IU/ml≤HBsAg≤3000 IU/ml.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100032
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Youan Hospital,Capital Medical
Beijing, Beijing Municipality, 100069
The Second Affiliated Hospital of Chongqing Medical
Chongqing, Chongqing Municipality, 401437
About this study
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
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.
- Conditions
- Chronic Hepatitis b
- Being tested
- STSG-0002 Injection
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSG-0002 InjectionDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| lowest dose treatment group | Experimental | Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements Receives: Drug: STSG-0002 Injection |
| low dose treatment group | Experimental | Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements Receives: Drug: STSG-0002 Injection |
| Intermediate dose treatment group | Experimental | Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements Receives: Drug: STSG-0002 Injection |
| A single high dose of treatment group | Experimental | Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements Receives: Drug: STSG-0002 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects of adverse events
Measured: Baseline to Day 180
Number of subjects With Significant Abnormal Physical Examination
Measured: Baseline to Day 180
Number of subjects of Significant Abnormal Vital Signs Findings
Measured: Baseline to Day 180
Number of Participants With Significant Abnormal Laboratory Values
Measured: Baseline to Day 180
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Measured: Baseline to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start25 Apr 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Why it stopped: The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Sanuo Jiayi Biotechnology Co. LTD
- Responsible party
- Sponsor
- Investigators
- Guiqiang Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760781
- Sponsor's protocol ID
- STS-STSG0002-002
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05760781
- Acronym / sponsor ID
- STS-STSG0002-002
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Sanuo Jiayi Biotechnology Co. LTD
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lowest dose treatment group | Experimental | Drug: STSG-0002 InjectionSubjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements |
| low dose treatment group | Experimental | Drug: STSG-0002 InjectionSubjects will receive one single low dose of STSG-0002 Injection following protocol requirements |
| Intermediate dose treatment group | Experimental | Drug: STSG-0002 InjectionSubjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements |
| A single high dose of treatment group | Experimental | Drug: STSG-0002 InjectionSubjects will receive one single high dose of STSG-0002 Injection following protocol requirements |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic HBV；
- Receiving anti-HB viral therapy;
- 10 IU/ml≤HBsAg≤3000 IU/ml.
Key exclusion criteria (7 listed)
- Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;
- Liver cirrhosis;
- Hepatocellular carcinoma;
- Autoimmune liver disease;
- Clinical hepatic decompensation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STSG-0002 InjectionIntravenous infusion | Drug | A single high dose of treatment group, Intermediate dose treatment group, low dose treatment group, lowest dose treatment group |
Primary outcome
Number of subjects of adverse events
Time frame: Baseline to Day 180
Number of subjects With Significant Abnormal Physical Examination
Time frame: Baseline to Day 180
Number of subjects of Significant Abnormal Vital Signs Findings
Time frame: Baseline to Day 180
Number of Participants With Significant Abnormal Laboratory Values
Time frame: Baseline to Day 180
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time frame: Baseline to Day 180
Results and safety
The study was stopped early (reason given: The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiqiang Wang principal investigator
Peking University First Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STSG-0002 Injection in people with Chronic Hepatitis b, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects of adverse events (time frame: Baseline to Day 180). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.