Hepatitis, AutoimmunePhase 4NCT04617561
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
A Phase 4 study testing Ursodeoxycholic acid and Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) in people with Hepatitis, Autoimmune 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 low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis, Autoimmune, Primary Biliary Cholangitis
- What is being tested?
- Ursodeoxycholic acid and Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 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 70 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 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, 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;
- Parenteral administration of blood or blood products within 6 months before screening;
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- Recent treatment with drugs having known liver toxicity;
- Taken part in other clinic trials within 6 months before enrollment.
- patients with contraindications of glucocorticoid
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Li Yang, MD, +86 18980601276, yangli_hx@scu.edu.cn
Chen Huang, +86 18328089415, huangchen0323@163.com
About this study
Official title: Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
- Conditions
- Hepatitis, Autoimmune, Primary Biliary Cholangitis
- Being tested
- Ursodeoxycholic acid, Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
- Keywords
- Glucocorticoid, Ursodeoxycholic Acid
- Medical subject headings
- Hepatitis, Autoimmune, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
Also called UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)Drug
Also called Medrol（4mg*30,pfizer ltalia srl)
Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic Acid group | Active comparator | Ursodeoxycholic Acid 13-15mg/kg/d Receives: Drug: Ursodeoxycholic acid |
| Ursodeoxycholic Acid+Low Dose Glucocorticoid group | Experimental | Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period Receives: Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) |
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 treatment, per treatment group.
Measured: up to 12 months
Secondary outcomes (6)
Partial remission
Partial remission, defined as ALT or 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
ALT,AST,IgG
serum ALT,AST and IgG levels
Measured: baseline and month 3,6,12
percentage of immune cells
percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT
Measured: baseline and month 12
Side-effects
Drug related side-effects
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 posted5 Nov 2020
- Study start1 Nov 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, AutoimmuneStudies 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
- 90 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617561
- Sponsor's protocol ID
- PBC With AIH Features II
- Status last verified
- Mar 2021
- First submitted
- 29 Oct 2020
- Last updated
- 22 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 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT04617561
- Acronym / sponsor ID
- PBC With AIH Features II
- Conditions
- Hepatitis, Autoimmune, Primary Biliary Cholangitis
- Keywords
- Glucocorticoid, Ursodeoxycholic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 5 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 low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic Acid group | Active comparator | Drug: Ursodeoxycholic acidUrsodeoxycholic Acid 13-15mg/kg/d |
| Ursodeoxycholic Acid+Low Dose Glucocorticoid group | Experimental | Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period |
Who may qualify
- Ages
- 18 to 70 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 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, 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;
- Severe disorders of other vital organs, such as severe heart failure, cancer;
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 acidAlso: UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)Participants received Ursodeoxycholic acid (13-15mg/kg/d po.) | Drug | Ursodeoxycholic Acid group |
| Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)Also: Medrol（4mg*30,pfizer ltalia srl)Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.) | Drug | Ursodeoxycholic Acid+Low Dose Glucocorticoid group |
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 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
ALT,AST,IgG
Time frame: baseline and month 3,6,12
percentage of immune cells
Time frame: baseline and month 12
Side-effects
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 22 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, China
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 and Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) in people with Hepatitis, Autoimmune 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 22 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 22 Mar 2021.