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出境医 / 临床实验 / 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 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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Primary Biliary Cirrhosis Drug: Methylprednisolone and Mycophenolate mofetil Drug: Methylprednisolone and azathioprine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Methylprednisolone and Mycophenolate mofetil Drug: Methylprednisolone and Mycophenolate mofetil
Methylprednisolone combination of mycophenolate mofetil
Active Comparator: Methylprednisolone and Azathioprine Drug: Methylprednisolone and azathioprine
Methylprednisolone combination of azathioprine
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
Contacts and Locations

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

Locations
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China, Sichuan
West China Hospital of Sichuan Univerisity Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xiaoli Fan, PhD         
Sponsors and Collaborators
Xiaoli Fan
Tracking Information
First Submitted Date  ICMJE May 1, 2020
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE June 16, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autoimmune Hepatitis
  • Primary Biliary Cirrhosis
Intervention  ICMJE
  • Drug: Methylprednisolone and Mycophenolate mofetil
    Methylprednisolone combination of mycophenolate mofetil
  • Drug: Methylprednisolone and azathioprine
    Methylprednisolone combination of azathioprine
Study Arms  ICMJE
  • Experimental: Methylprednisolone and Mycophenolate mofetil
    Intervention: Drug: Methylprednisolone and Mycophenolate mofetil
  • Active Comparator: Methylprednisolone and Azathioprine
    Intervention: Drug: Methylprednisolone and azathioprine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaoli Fan, Master degree +86 13980433451 13980433451@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04933292
Other Study ID Numbers  ICMJE OS-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaoli Fan, West China Hospital
Study Sponsor  ICMJE Xiaoli Fan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account West China Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP