Autoimmune HepatitisPhase 2NCT05476900
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
A Phase 2 study testing HR19042 Capsules in people with Autoimmune Hepatitis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- HR19042 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2022to 14 Mar 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old≤Female or male patients≤70 years old；
- Clinical-confirmed autoimmune hepatitis；
- Biopsy-confirmed autoimmune hepatitis；
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
- Willing and able to give informed consent and follow the protocols during the trial.
Who cannot join
- Patients with other chronic liver diseases；
- Patients with liver cirrhosis；
- Patients with hepatic encephalopathy；
- Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
- Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
- Patients with severe cardiovascular diseases；
Show all 10Show fewer
- Patients with malignancy within the past 5 years；
- Patients received organ transplantation；
- Patients treated with any systemic corticosteroids within 3 months before screening；
- Patients treated with any systemic immunosuppressive drugs within the 6 months before screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200120
About this study
Official title: A Randomized, Open-label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment.
- Conditions
- Autoimmune Hepatitis
- Being tested
- HR19042 Capsules
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR19042 CapsulesDrug
HR19042 Capsules
| Study group | Role | What they receive |
|---|---|---|
| 12 mg HR19042 Capsules QD | Experimental | Not described Receives: Drug: HR19042 Capsules |
| 4 mg HR19042 Capsules TID | Experimental | Not described Receives: Drug: HR19042 Capsules |
| 8 mg HR19042 Capsules QD | Experimental | Not described Receives: Drug: HR19042 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of biochemical response after 12 weeks of treatment.
Measured: 12 weeks
Secondary outcomes (7)
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
Measured: 12 weeks
Percentage of partial response after 12 weeks of treatment
Measured: 12 weeks
Percentage of biochemical response after 24 weeks of treatment.
Measured: 24 weeks
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
Measured: 24 weeks
Percentage of partial response after 24 weeks of treatment.
Measured: 24 weeks
Change from baseline in serum ALT levels.
Measured: 2, 4, 8, 12, 18, 24 weeks
Change from baseline in serum AST levels.
Measured: 2, 4, 8, 12, 18, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start6 Oct 2022
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- A randomized, open-label, multicenter, parallel groups, Phase II clinical trial
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476900
- Sponsor's protocol ID
- HR19042-202
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2022
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
- ClinicalTrials.gov ID
- NCT05476900
- Acronym / sponsor ID
- HR19042-202
- Conditions
- Autoimmune Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 27 Jul 2022 (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.
This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized, open-label, multicenter, parallel groups, Phase II clinical trial
| Arm | Type | Receives |
|---|---|---|
| 12 mg HR19042 Capsules QD | Experimental | Drug: HR19042 Capsules |
| 4 mg HR19042 Capsules TID | Experimental | Drug: HR19042 Capsules |
| 8 mg HR19042 Capsules QD | Experimental | Drug: HR19042 Capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old≤Female or male patients≤70 years old；
- Clinical-confirmed autoimmune hepatitis；
- Biopsy-confirmed autoimmune hepatitis；
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
- Willing and able to give informed consent and follow the protocols during the trial.
Key exclusion criteria (10 listed)
- Patients with other chronic liver diseases；
- Patients with liver cirrhosis；
- Patients with hepatic encephalopathy；
- Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
- Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
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 |
|---|---|---|
| HR19042 CapsulesHR19042 Capsules | Drug | 12 mg HR19042 Capsules QD, 4 mg HR19042 Capsules TID, 8 mg HR19042 Capsules QD |
Primary outcome
Percentage of biochemical response after 12 weeks of treatment.
Time frame: 12 weeks
7 secondary outcomes
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
Time frame: 12 weeks
Percentage of partial response after 12 weeks of treatment
Time frame: 12 weeks
Percentage of biochemical response after 24 weeks of treatment.
Time frame: 24 weeks
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
Time frame: 24 weeks
Percentage of partial response after 24 weeks of treatment.
Time frame: 24 weeks
Change from baseline in serum ALT levels.
Time frame: 2, 4, 8, 12, 18, 24 weeks
Change from baseline in serum AST levels.
Time frame: 2, 4, 8, 12, 18, 24 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 24 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Autoimmune Hepatitis
RecruitingPhase 3
A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
Autoimmune Hepatitis, AIH
RecruitingPhase 2
Belimumab in Autoimmune Hepatitis
Autoimmune Hepatitis
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingObservational study
Thyroid Disorders in Pediatric Autoimmune Hepatitis
Thyroid Disease, Autoimmune Hepatitis
RecruitingObservational study
A-LiNK: Improving Outcomes in Autoimmune Liver Disease
Autoimmune Hepatitis, Primary Sclerosing Cholangitis
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 HR19042 Capsules in people with Autoimmune Hepatitis, run by Jiangsu HengRui 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 5 inclusion and 10 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 24 Mar 2025. 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. 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?
Percentage of biochemical response after 12 weeks of treatment. (time frame: 12 weeks). 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 24 Mar 2025.