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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)

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HRS9950 tablets
HRS9950 tablets
HRS9950 placebo tablets
Sponsored by
Chengdu Suncadia Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Nanfang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment group A: HRS9950 tablets (Low dose)

Treatment group B: HRS9950 tablets (High dose)

Placebo Comparator: Treatment group C

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
Proportion of subjects with serum hepatitis B surface antigen loss
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Proportion of subjects with hepatitis B e-antigen loss
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Proportion of subjects with virologic breakthrough
Proportion of subjects with drug resistance

Full Information

First Posted
June 7, 2023
Last Updated
September 5, 2023
Sponsor
Chengdu Suncadia Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05905458
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
July 18, 2024 (Anticipated)
Study Completion Date
January 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Suncadia Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A: HRS9950 tablets (Low dose)
Arm Type
Experimental
Arm Title
Treatment group B: HRS9950 tablets (High dose)
Arm Type
Experimental
Arm Title
Placebo Comparator: Treatment group C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HRS9950 tablets
Intervention Description
HRS9950 tablets, oral, once a week, low dose
Intervention Type
Drug
Intervention Name(s)
HRS9950 tablets
Intervention Description
HRS9950 tablets, oral, once a week, high dose
Intervention Type
Drug
Intervention Name(s)
HRS9950 placebo tablets
Intervention Description
HRS9950 placebo tablets, oral, once a week.
Primary Outcome Measure Information:
Title
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with serum hepatitis B surface antigen loss
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with hepatitis B e-antigen loss
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with virologic breakthrough
Time Frame
Pre-specified time points up to 48 weeks
Title
Proportion of subjects with drug resistance
Time Frame
Pre-specified time points up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaopeng Wang
Phone
0518-82342973
Email
xiaopeng.wang@hengrui.com
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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)

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