Chronic Hepatitis B
Conditions
Brief summary
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.
Interventions
Sponsors
Suzhou HepaThera Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects were eligible for inclusion into the study if they met each of the following 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
* Subjects were excluded from the study if one or more of the following criteria were applicable Participants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg loss rate at W24, W36, W60 | From enrollment to the end of treatment at up to 60 weeks | — |
| Maximum Change of Serum HBsAg From Baseline Description | Up to 36 weeks | 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) |
| Maximum Change of Serum HBV DNA From Baseline Description | Up to 36 weeks. | Maximum change of serum HBV DNA from Day 1 until 36 weeks (negative values mean reductions from baseline, positive values mean increased from baseline) |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | From enrollment to the end of treatment at up to 60 weeks | Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| 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 | — |
| Maximum Plasma Concentration (Cmax) | HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks. | 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. |
| Time to Reach Maximum Plasma Concentration (Tmax) | HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks. | 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. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks. | 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. |
| Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101 | UP to 36 weeks | ADA analysis for predose 36weeks |
| Clinically significant abnormalities | From enrollment to the end of treatment at up to 60 weeks | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0 |
Countries
China
Outcome results
None listed