HepatitisPhase 4NCT04618575
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
A Phase 4 study testing Ursodeoxycholic acid combined with total glucosides of paeony and Ursodeoxycholic acid only in people with Hepatitis and Primary Biliary Cholangitis, run by West China Hospital at 1 site in China.
Trial summary
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis, Primary Biliary Cholangitis, Autoimmune
- What is being tested?
- Ursodeoxycholic acid combined with total glucosides of paeony and Ursodeoxycholic acid only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2021to 5 Nov 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years;
- The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 1.0xULN < ALT ≤ 3.0xULN or 1.0xULN < AST ≤ 3.0xULN or 1.0xULN < IgG ≤ 1.3xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
- Agreed to participate in the trial, and assigned informed consent.
Who cannot join
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of cirrhosis;
- Patients with presence of fulminant liver failure;
- Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease;
- Pregnant and breeding women and women of childbearing age in need of reproduction;
- Severe disorders of other vital organs, such as severe heart failure, cancer;
Show all 9Show fewer
- Parenteral administration of blood or blood products within 6 months before screening;
- Recent treatment with drugs having known liver toxicity;
- Taken part in other clinic trials within 6 months before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Li Yang, MD, +8618980601276, yangli_hx@scu.edu.cn
About this study
Official title: A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
- Conditions
- Hepatitis, Primary Biliary Cholangitis, Autoimmune
- Being tested
- Ursodeoxycholic acid combined with total glucosides of paeony, Ursodeoxycholic acid only
- Medical subject headings
- Hepatitis, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acid combined with total glucosides of paeonyDrug
Ursodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid onlyDrug
Ursodeoxycholic acid only
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic acid combined with total glucosides of paeony | Experimental | Not described Receives: Drug: Ursodeoxycholic acid combined with total glucosides of paeony |
| Ursodeoxycholic acid only | Other | Not described Receives: Drug: Ursodeoxycholic acid only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical remission
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
Measured: up to 12 months
Secondary outcomes (6)
Partial remission
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Measured: up to 12 months
Minimal response
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Measured: up to 12 months
Treatment failure
defined as no improvement or increase of ALT or AST serum levels
Measured: up to 12 months
Side-effects
Drug related side-effects
Measured: up to 12 months
Clinical symptoms
Jaundice, fatigue, itching, etc
Measured: up to 12 months
Changes in the proportion of blood immune cells
percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start17 Mar 2021
- Primary completion5 Nov 2022 (estimated)
- Study completion5 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, West China Hospital
- Investigators
- Li Yang, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618575
- Sponsor's protocol ID
- PBC with AIH features 1
- Status last verified
- Mar 2021
- First submitted
- 31 Oct 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
- ClinicalTrials.gov ID
- NCT04618575
- Acronym / sponsor ID
- PBC with AIH features 1
- Conditions
- Hepatitis, Primary Biliary Cholangitis, Autoimmune
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 5 Nov 2022 (estimated)
- Study completion
- 5 Nov 2022 (estimated)
- First posted
- 6 Nov 2020 (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.
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic acid combined with total glucosides of paeony | Experimental | Drug: Ursodeoxycholic acid combined with total glucosides of paeony |
| Ursodeoxycholic acid only | Other | Drug: Ursodeoxycholic acid only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-75 years;
- The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 1.0xULN < ALT ≤ 3.0xULN or 1.0xULN < AST ≤ 3.0xULN or 1.0xULN < IgG ≤ 1.3xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
- Agreed to participate in the trial, and assigned informed consent.
Key exclusion criteria (9 listed)
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of cirrhosis;
- Patients with presence of fulminant liver failure;
- Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease;
- Pregnant and breeding women and women of childbearing age in need of reproduction;
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 |
|---|---|---|
| Ursodeoxycholic acid combined with total glucosides of paeonyUrsodeoxycholic acid combined with total glucosides of paeony | Drug | Ursodeoxycholic acid combined with total glucosides of paeony |
| Ursodeoxycholic acid onlyUrsodeoxycholic acid only | Drug | Ursodeoxycholic acid only |
Primary outcome
Biochemical remission
Time frame: up to 12 months
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
6 secondary outcomes
Partial remission
Time frame: up to 12 months
Minimal response
Time frame: up to 12 months
Treatment failure
Time frame: up to 12 months
Side-effects
Time frame: up to 12 months
Clinical symptoms
Time frame: up to 12 months
Changes in the proportion of blood immune cells
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatitis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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.
Li Yang, MD study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ursodeoxycholic acid combined with total glucosides of paeony and Ursodeoxycholic acid only in people with Hepatitis and Primary Biliary Cholangitis, run by West China Hospital 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengyi Shen, MD (+86 15626212342, shenmengyi1219@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical remission (time frame: up to 12 months). 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 2021.