Hepatitis, AutoimmunePhase 4NCT04376528
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
A Phase 4 study testing Cyclosporin A and Mycophenolate Mofetil in people with Hepatitis, Autoimmune and Primary Biliary Cholangitis, run by West China Hospital at 1 site in China.
Trial summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis, Autoimmune, Primary Biliary Cholangitis, Immunosuppression
- What is being tested?
- Cyclosporin A and Mycophenolate Mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to 30 Dec 2021
- 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 18-70 years;
- Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- Patients have a nonresponse to azathioprine;
- The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
- 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 serious decompensated cirrhosis;
- Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
- 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;
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- Patients with presence of renal insufficiency;
- 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.
- Patients who are allergic to these drugs;
- Uncontrolled infection and hypertension ;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
WestChina Hospital
Chengdu, Sichuan, 610041
Li Yang, +86 13518178110, yangli_hx@scu.edu.cn
About this study
Official title: Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
- Being tested
- Cyclosporin A, Mycophenolate Mofetil
- 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.
Cyclosporin ADrug
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporin A | Experimental | Not described Receives: Drug: Cyclosporin A |
| Mycophenolate Mofetil | Active comparator | Not described Receives: Drug: Mycophenolate Mofetil |
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 6 months
Secondary outcomes (5)
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 6 months
Minimal response
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Measured: up to 6 months
Treatment failure
defined as no improvement or increase of ALT or AST serum levels
Measured: up to 6 months
Changes in liver stiffness
liver stiffness will be measured by shear-wave elastography
Measured: up to 6 months
Side-effects
Drug related side-effects
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start16 Jun 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (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
- 89 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
- NCT04376528
- Sponsor's protocol ID
- OS-3
- Status last verified
- May 2021
- First submitted
- 3 May 2020
- Last updated
- 22 Jun 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 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy
- ClinicalTrials.gov ID
- NCT04376528
- Acronym / sponsor ID
- OS-3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 6 May 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.
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporin A | Experimental | Drug: Cyclosporin A |
| Mycophenolate Mofetil | Active comparator | Drug: Mycophenolate Mofetil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-70 years;
- Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- Patients have a nonresponse to azathioprine;
- The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
- Agreed to participate in the trial, and assigned informed consent;
Key exclusion criteria (12 listed)
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of serious decompensated cirrhosis;
- Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
- 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 |
|---|---|---|
| Cyclosporin AUrsodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A) | Drug | Cyclosporin A |
| Mycophenolate MofetilUrsodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil ) | Drug | Mycophenolate Mofetil |
Primary outcome
Biochemical remission
Time frame: up to 6 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.
5 secondary outcomes
Partial remission
Time frame: up to 6 months
Minimal response
Time frame: up to 6 months
Treatment failure
Time frame: up to 6 months
Changes in liver stiffness
Time frame: up to 6 months
Side-effects
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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.
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 Cyclosporin A and Mycophenolate Mofetil 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 5 inclusion and 12 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 Jun 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 Xiaoli Fan, Master degree (+86 13980433451, 13980433451@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 6 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 Jun 2021.