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)

Chronic Hepatitis B Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05905458
• Other study ID #: HRS9950-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 28, 2023
• Est. completion date: January 25, 2025

Study information

• Verified date: June 2023
• Source: Chengdu Suncadia Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: January 25, 2025
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• HRS9950 tablets
HRS9950 tablets, oral, once a week, low dose
• HRS9950 tablets
HRS9950 tablets, oral, once a week, high dose
• HRS9950 placebo tablets
HRS9950 placebo tablets, oral, once a week.

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24		Week 24
Secondary	Changes from baseline in mean log10 serum hepatitis B surface antigen levels		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with serum hepatitis B surface antigen loss		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with serum hepatitis B surface antigen seroconversion		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with hepatitis B e-antigen loss		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with serum hepatitis B e-antigen seroconversion		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with virologic breakthrough		Pre-specified time points up to 48 weeks
Secondary	Proportion of subjects with drug resistance		Pre-specified time points up to 48 weeks