Chronic Hepatitis BPhase 2NCT05905458
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 study testing HRS9950 tablets in people with Chronic Hepatitis B, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HRS9950 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2023to 22 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- HRS9950 tablets, HRS9950 placebo tablets
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9950 tabletsDrug
HRS9950 tablets, oral, once a week, low dose
HRS9950 tabletsDrug
HRS9950 tablets, oral, once a week, high dose
HRS9950 placebo tabletsDrug
HRS9950 placebo tablets, oral, once a week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS9950 tablets (Low dose) | Experimental | Not described Receives: Drug: HRS9950 tablets |
| Treatment group B: HRS9950 tablets (High dose) | Experimental | Not described Receives: Drug: HRS9950 tablets |
| Placebo Comparator: Treatment group C | Placebo comparator | Not described Receives: Drug: HRS9950 placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
Measured: Week 24
Secondary outcomes (8)
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Measured: 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
Measured: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen loss
Measured: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Measured: Pre-specified time points up to 48 weeks
Proportion of subjects with hepatitis B e-antigen loss
Measured: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Measured: Pre-specified time points up to 48 weeks
Proportion of subjects with virologic breakthrough
Measured: Pre-specified time points up to 48 weeks
Proportion of subjects with drug resistance
Measured: Pre-specified time points up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start28 Jul 2023
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905458
- Sponsor's protocol ID
- HRS9950-201
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05905458
- Acronym / sponsor ID
- HRS9950-201
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9950 tabletsHRS9950 tablets, oral, once a week, low dose | Drug | Treatment group A: HRS9950 tablets (Low dose) |
| HRS9950 tabletsHRS9950 tablets, oral, once a week, high dose | Drug | Treatment group B: HRS9950 tablets (High dose) |
| HRS9950 placebo tabletsHRS9950 placebo tablets, oral, once a week. | Drug | Placebo Comparator: Treatment group C |
Primary outcome
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
Time frame: Week 24
8 secondary outcomes
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Time frame: 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
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen loss
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with hepatitis B e-antigen loss
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with virologic breakthrough
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with drug resistance
Time frame: Pre-specified time points up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS9950 tablets in people with Chronic Hepatitis B, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.