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CompletedNCT05905458Updated Dec 3, 2024

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)

A Phase 2 interventional study of HRS9950 tablets and HRS9950 tablets in Chronic Hepatitis B, sponsored by Chengdu Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Chengdu Suncadia Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 54 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd. is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Treatment group A: HRS9950 tablets (Low dose)

    Drug: HRS9950 tablets

  • Experimental
    Treatment group B: HRS9950 tablets (High dose)

    Drug: HRS9950 tablets

  • Placebo comparator
    Placebo Comparator: Treatment group C

    Drug: HRS9950 placebo tablets

Interventions

  • DrugHRS9950 tablets

    HRS9950 tablets, oral, once a week, low dose

  • DrugHRS9950 tablets

    HRS9950 tablets, oral, once a week, high dose

  • DrugHRS9950 placebo tablets

    HRS9950 placebo tablets, oral, once a week.

06

What researchers measure

Primary outcomes

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

    Time frame: Week 24

Secondary outcomes

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

    Time frame: Pre-specified time points up to 48 weeks

  2. 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

  3. Proportion of subjects with serum hepatitis B surface antigen loss

    Time frame: Pre-specified time points up to 48 weeks

  4. Proportion of subjects with serum hepatitis B surface antigen seroconversion

    Time frame: Pre-specified time points up to 48 weeks

  5. Proportion of subjects with hepatitis B e-antigen loss

    Time frame: Pre-specified time points up to 48 weeks

  6. Proportion of subjects with serum hepatitis B e-antigen seroconversion

    Time frame: Pre-specified time points up to 48 weeks

  7. Proportion of subjects with virologic breakthrough

    Time frame: Pre-specified time points up to 48 weeks

  8. Proportion of subjects with drug resistance

    Time frame: Pre-specified time points up to 48 weeks

07

Study locations

1 site
  • Nanfang Hospital
    Guangzhou, Guangdong 510515, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05905458
Lead sponsor
Chengdu Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Jul 28, 2023
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024
Last update
Dec 3, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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