Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT07088133
Brief Summary:
* Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). The primary efficacy endpoints are HBsAg seroconversion rate (HBsAg disappearance and HBsAb appearance), and HCC recurrence rate at week 49. Secondary Objective: To evaluate the safety of the HBV sandwich combination therapy through various safety indicators. Safety Indicators as follows: 1) Vital Signs: Monitoring systolic and diastolic blood pressure, pulse, respiration, and body temperature; 2) Physical Examination: Comprehensive physical assessments during the study; 3) 12-lead Electrocardiogram: Conducted to monitor cardiac health; 4) Clinical Laboratory Tests: Including blood routine, urine routine, blood biochemistry (focusing on liver and kidney function), coagulation function; 5) Injection Site Reactions: Monitoring for any local adverse effects from injections; 6) Adverse Events (AEs) and Serious Adverse Events (SAEs): Documentation of any AEs or SAEs occurring during treatment.
* Study Design: This study comprises three distinct stages:
1. Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations.
2. Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU/mL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU/mL post HT-102, participants will enter the follow-up period directly.
3. Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters.
* End of Study:
The study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.
\- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.
Study:
NCT07088133
Study Brief:
Protocol Section:
NCT07088133