Autoimmune HepatitisPhase 4NCT04933292
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
A Phase 4 study testing Methylprednisolone and Mycophenolate mofetil and Methylprednisolone and azathioprine in people with Autoimmune Hepatitis and Primary Biliary Cirrhosis, run by Xiaoli Fan at 1 site in China.
Trial summary
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Hepatitis, Primary Biliary Cirrhosis
- What is being tested?
- Methylprednisolone and Mycophenolate mofetil and Methylprednisolone and azathioprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to May 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 18-70 years;
- Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- Agreed to participate in the trial, and assigned informed consent;
- The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
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 disease.
- Pregnant and breeding women;
- Severe disorders of other vital organs, such as severe heart failure, cancer;
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- 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 of Sichuan Univerisity
Chengdu, Sichuan, 610041
Xiaoli Fan, PhD
About this study
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cirrhosis
- Being tested
- Methylprednisolone and Mycophenolate mofetil, Methylprednisolone and azathioprine
- 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.
Methylprednisolone and Mycophenolate mofetilDrug
Methylprednisolone combination of mycophenolate mofetil
Methylprednisolone and azathioprineDrug
Methylprednisolone combination of azathioprine
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone and Mycophenolate mofetil | Experimental | Not described Receives: Drug: Methylprednisolone and Mycophenolate mofetil |
| Methylprednisolone and Azathioprine | Active comparator | Not described Receives: Drug: Methylprednisolone and azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical remission
The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group
Measured: 6 months
Secondary outcomes (4)
The level of IgG value in both groups
Measured: at 1 month
The level of IgG value in both groups
Measured: at 3-month
The level of IgG value in both groups
Measured: at 6-month
Adverse drug reactions
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 posted21 Jun 2021
- Study start16 Jun 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
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.
- 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoli Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoli Fan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933292
- Sponsor's protocol ID
- OS-2
- Status last verified
- Jun 2021
- First submitted
- 1 May 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
- ClinicalTrials.gov ID
- NCT04933292
- Acronym / sponsor ID
- OS-2
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Xiaoli FanUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 21 Jun 2021 (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.
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone and Mycophenolate mofetil | Experimental | Drug: Methylprednisolone and Mycophenolate mofetil |
| Methylprednisolone and Azathioprine | Active comparator | Drug: Methylprednisolone and azathioprine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-70 years;
- Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- Agreed to participate in the trial, and assigned informed consent;
- The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
Key exclusion criteria (9 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 disease.
- Pregnant and breeding women;
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 |
|---|---|---|
| Methylprednisolone and Mycophenolate mofetilMethylprednisolone combination of mycophenolate mofetil | Drug | Methylprednisolone and Mycophenolate mofetil |
| Methylprednisolone and azathioprineMethylprednisolone combination of azathioprine | Drug | Methylprednisolone and Azathioprine |
Primary outcome
Biochemical remission
Time frame: 6 months
The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group
4 secondary outcomes
The level of IgG value in both groups
Time frame: at 1 month
The level of IgG value in both groups
Time frame: at 3-month
The level of IgG value in both groups
Time frame: at 6-month
Adverse drug reactions
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 21 Jun 2021.
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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 Methylprednisolone and Mycophenolate mofetil and Methylprednisolone and azathioprine in people with Autoimmune Hepatitis and Primary Biliary Cirrhosis, run by Xiaoli Fan 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 4 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 21 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: 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 21 Jun 2021.