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Status unknownNCT04933292Updated Jun 21, 2021

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 interventional study of Methylprednisolone and Mycophenolate mofetil and Methylprednisolone and azathioprine in Autoimmune Hepatitis and Primary Biliary Cirrhosis, sponsored by Xiaoli Fan. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-21.

Sponsored by Xiaoli Fan · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Autoimmune Hepatitis
  • Primary Biliary Cirrhosis
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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 78 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Xiaoli Fan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients aged 18-70 years;
  2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
  3. Agreed to participate in the trial, and assigned informed consent;
  4. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.

Exclusion criteria

Exclusion Criteria:

  1. The presence of hepatitis A, B, C, D, or E virus infection;
  2. Patients with presence of serious decompensated cirrhosis;
  3. Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
  4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease.
  5. Pregnant and breeding women;
  6. Severe disorders of other vital organs, such as severe heart failure, cancer;
  7. Parenteral administration of blood or blood products within 6 months before screening;
  8. Recent treatment with drugs having known liver toxicity;
  9. Taken part in other clinic trials within 6 months before enrollment.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Methylprednisolone and Mycophenolate mofetil

    Drug: Methylprednisolone and Mycophenolate mofetil

  • Active comparator
    Methylprednisolone and Azathioprine

    Drug: Methylprednisolone and azathioprine

Interventions

  • DrugMethylprednisolone and Mycophenolate mofetil

    Methylprednisolone combination of mycophenolate mofetil

  • DrugMethylprednisolone and azathioprine

    Methylprednisolone combination of azathioprine

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. The level of IgG value in both groups

    Time frame: at 1 month

  2. The level of IgG value in both groups

    Time frame: at 3-month

  3. The level of IgG value in both groups

    Time frame: at 6-month

  4. Adverse drug reactions

    Time frame: up to 6 months

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Study locations

1 of 1 sites recruiting
  • West China Hospital of Sichuan Univerisity
    Chengdu, Sichuan 610041, China
    • Xiaoli Fan, PhD · Contact
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04933292
Lead sponsor
Xiaoli Fan
Responsible party
Xiaoli Fan (Doctor, West China Hospital) — Sponsor-investigator
First posted
Jun 21, 2021
Start date
Jun 16, 2021
Primary completion
May 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Jun 21, 2021

Study contacts

Xiaoli Fan, Master degree
Contact
13980433451@163.com
+86 13980433451

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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