Clinical trial NCT05905458: A Phase II Clinical Study of the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).


Eligibility criteria: Inclusion Criteria:

1. Meet the body mass index standard among 18.0 to 30 kg/m2;；
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 12 weeks before randomization;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.

Exclusion Criteria:

1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
2. With autoimmune disease;
3. With poorly-controlled diabetes, thyroid disease requiring clinical intervention, clinically significant thyroid dysfunction, neurological or psychiatric disorder, severe lung disease, chronic renal disease or retinopathy;
4. History of solid organ transplantation or hematopoietic stem cell transplantation;
5. Poorly-controlled hypertension, clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
6. Malignant tumors were diagnosed within 5 years prior to randomization；
7. Infection requiring intervention within 4 weeks prior to randomization;
8. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
9. Laboratory tests during the screening period were obviously abnormal;
10. Prolonged ECG QTc interval (male \> 450ms, female \> 470ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
11. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
12. Participated in clinical study of other drugs (received experimental drugs);
13. Pregnant or nursing women;
14. Allergic to a drug ingredient or component;
15. Other reasons for ineligibility as judged by the investigators.

Primary outcomes:
measure: Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
timeFrame: Week 24
Secondary outcomes:
measure: Changes from baseline in mean log10 serum hepatitis B surface antigen levels
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with serum hepatitis B surface antigen loss
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with serum hepatitis B surface antigen seroconversion
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with hepatitis B e-antigen loss
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with serum hepatitis B e-antigen seroconversion
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with virologic breakthrough
timeFrame: Pre-specified time points up to 48 weeks
measure: Proportion of subjects with drug resistance
timeFrame: Pre-specified time points up to 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: