NCT05760703

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

February 23, 2023

Last Update Submit

December 13, 2023

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (5)

  • Number of subjects of adverse events

    Baseline to Day 180

  • Number of subjects With Significant Abnormal Physical Examination

    Baseline to Day 180

  • Number of subjects of Significant Abnormal Vital Signs Findings

    Baseline to Day 180

  • Number of Participants With Significant Abnormal Laboratory Values

    Baseline to Day 180

  • Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings

    Baseline to Day 180

Study Arms (4)

lowest dose treatment group

EXPERIMENTAL

Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements

Drug: STSG-0002 Injection

low dose treatment group

EXPERIMENTAL

Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements

Drug: STSG-0002 Injection

Intermediate dose treatment group

EXPERIMENTAL

Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements

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

Drug: STSG-0002 Injection

Interventions

STSG-0002 InjectionDRUG

Intravenous infusion

A single high dose of treatment groupIntermediate dose treatment grouplow dose treatment grouplowest dose treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic HBV；
  • Receiving anti-HB viral therapy；
  • IU/ml≤HBsAg≤3000 IU/ml.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Peking University First Hospital

Beijing, Beijing Municipality, 100032, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Youan Hospital,Capital Medical

Beijing, Beijing Municipality, 100069, China

Location

The Second Affiliated Hospital of Chongqing Medical

Chongqing, Chongqing Municipality, 401437, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guiqiang Wang

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 8, 2023

Study Start

April 25, 2023

Primary Completion

December 11, 2023

Study Completion

December 11, 2023

Last Updated

December 19, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)