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)

NCT05905458 | Completed Phase 2

• 1 other identifier: HRS9950-201
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24

  Week 24

Secondary Outcomes (8)

• Changes from baseline in mean log10 serum hepatitis B surface antigen levels

  Pre-specified time points up to 48 weeks

• 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

• Proportion of subjects with serum hepatitis B surface antigen loss

  Pre-specified time points up to 48 weeks

• Proportion of subjects with serum hepatitis B surface antigen seroconversion

  Pre-specified time points up to 48 weeks

• Proportion of subjects with hepatitis B e-antigen loss

  Pre-specified time points up to 48 weeks

Study Arms (3)

Treatment group A: HRS9950 tablets (Low dose)

EXPERIMENTAL

Drug: HRS9950 tablets

Treatment group B: HRS9950 tablets (High dose)

EXPERIMENTAL

Drug: HRS9950 tablets

Placebo Comparator: Treatment group C

PLACEBO COMPARATOR

Drug: HRS9950 placebo tablets

Interventions

HRS9950 tablets DRUG

HRS9950 tablets, oral, once a week, low dose

Treatment group A: HRS9950 tablets (Low dose)

HRS9950 placebo tablets DRUG

HRS9950 placebo tablets, oral, once a week.

Placebo Comparator: Treatment group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the body mass index standard among 18.0 to 30 kg/m2;；
• Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
• Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
• 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;
• Need to take effective contraceptive measures；
• Volunteer to sign an informed consent.

You may not qualify if:

• 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;
• With autoimmune disease;
• 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;
• History of solid organ transplantation or hematopoietic stem cell transplantation;
• Poorly-controlled hypertension, clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
• Malignant tumors were diagnosed within 5 years prior to randomization；
• Infection requiring intervention within 4 weeks prior to randomization;
• 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;
• Laboratory tests during the screening period were obviously abnormal;
• 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;
• History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
• Participated in clinical study of other drugs (received experimental drugs);
• Pregnant or nursing women;
• Allergic to a drug ingredient or component;
• Other reasons for ineligibility as judged by the investigators.

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: July 28, 2023
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: December 3, 2024

Record last verified: 2023-06

Locations

CN (1)