Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B. It consists of two phases: the main trial and the extension period. The main trial phase aims to explore the efficacy of different courses of HT-101 injection combined with HT-102 injection in treating patients with chronic hepatitis B and evaluate the optimal treatment strategy. The extension period phase, based on the main trial, assesses the long-term safety and efficacy of HT-101 injection combined with HT-102 injection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (HT-101 + HT-102) | Experimental | Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks |
|
| Cohort B (placebo;HT-101+HT-102) | Experimental | Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HT-101 | Drug | HT-101 given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60 | From enrollment to the end of treatment at up to 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving HBV DNA lower than LLOQ after stopping all anti-HBV treatment | From enrollment to the end of treatment at up to 60 weeks | |
| HBsAg loss rate at W24, W36, W60 | From enrollment to the end of treatment at up to 60 weeks |
Not provided
Inclusion Criteria:
Patient with CHB Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 kg/m^2 (inclusive); Chronic HBV infection for >/= 6 months; The quantitation level of HBsAg was > 100 IU/mL and <3000 IU/mL; The quantitation level of HBV DNA <LLOQ;
· On Nas therapy for >/= 6 months at the time of screening Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jinlin Hou | Nanfang Hospital, Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Mengchao Hepatobiliary Hospital of Fujian Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
| HT-102 | Drug | HT-102 given by subcutaneous injection |
|
| HT-101 placebo | Drug | HT-101 placebo given by subcutaneous injection |
|
| HT-102 placebo | Drug | HT-102 placebo given by subcutaneous injection |
|
| Maximum Change of Serum HBsAg From Baseline Description | Maximum change of serum HBsAg from Day 1 until 36 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline) | Up to 36 weeks |
| Maximum Change of Serum HBV DNA From Baseline Description | Maximum change of serum HBV DNA from Day 1 until 36 weeks (negative values mean reductions from baseline, positive values mean increased from baseline) | Up to 36 weeks. |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From enrollment to the end of treatment at up to 60 weeks |
| Clinically significant abnormalities | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0 | From enrollment to the end of treatment at up to 60 weeks |
| Maximum Plasma Concentration (Cmax) | Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks. | HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks. |
| Time to Reach Maximum Plasma Concentration (Tmax) | Tmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks. | HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks. | HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks. |
| Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101 | ADA analysis for predose 36weeks | UP to 36 weeks |
| Fuzhou |
| Fujian |
| 350028 |
| China |
| Guangzhou Eighth People's Hospital, Guangzhou Medical University | Guangzhou | Guangdong | 510440 | China |
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| Qingyuan People's Hospital | Qingyuan | Guangdong | 511518 | China |
| Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine | Nanning | Guangxi | 530011 | China |
| Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou | Zhengzhou | Henan | 450000 | China |
| The Second Hospital of Nanjing | Nanjing | Jiangsu | 210003 | China |
| Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital) | Zhenjiang | Jiangsu | 212021 | China |
| Nanchang Ninth Hospital | Nanchang | Jiangxi | 330022 | China |
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 200083 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided