Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 70 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02936596
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoli Fan, West China Hospital

Brief Summary:
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Condition or disease Intervention/treatment Phase
Hepatitis, Autoimmune Cholangitis Liver Cirrhosis, Biliary Cholestasis Drug: Ursodeoxycholic acid combination of immunosuppressive agents Drug: Ursodeoxycholic Acid Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents
Study Start Date : December 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Experimental: Ursodeoxycholic acid + immunosuppressive agents group
Ursodeoxycholic acid + immunosuppressive agents
Drug: Ursodeoxycholic acid combination of immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)

Active Comparator: Ursodeoxycholic acid group
Ursodeoxycholic acid
Drug: Ursodeoxycholic Acid
Ursodeoxycholic Acid




Primary Outcome Measures :
  1. Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH) [ Time Frame: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents ]

Secondary Outcome Measures :
  1. Alanine transaminase (ALT) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  2. Aspartate transaminase(AST) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  3. Immunoglobulin G(IgG) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  4. Globin(GLB) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  5. Total bilirubin(TB) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  6. Direct bilirubin(DB) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  7. Alkaline phosphatase(ALP) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  8. Glutamyltransferase(GGT) [ Time Frame: Week 2 and Month 1, 3, 6 ]
  9. Side effects [ Time Frame: Evaluation of side effects during the study period(6 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 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 primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
  • 3.White blood cell count ≥2.5x10^9/L or platelet count ≥50x10^9/L at inclusion;
  • 4.Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

  • 1. The presence of hepatitis A, B, C, D, or E virus infection;
  • 2. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN),or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.
  • 3. Patients with complications of cirrhosis;
  • 4. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
  • 5. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
  • 6. Pregnant and breeding women;
  • 7. Severe disorders of other vital organs, such as severe heart failure, cancer;
  • 8. Parenteral administration of blood or blood products within 6 months before screening;
  • 9. Recent treatment with drugs having known liver toxicity;
  • 10.Taken part in other clinic trials within 6 months before screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936596


Contacts
Layout table for location contacts
Contact: Xiaoli Fan, MM +862885422311 13980433451@163.com

Locations
Layout table for location information
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xiaoli Fan, MM    +8618008028017    13980433451@163.com   
Contact: Li Yang, MD       yangli_hx@scu.edu.cn   
Sponsors and Collaborators
Xiaoli Fan
Investigators
Layout table for investigator information
Study Chair: Li Yang, MD West China Hospital,Chengdu, Sichuan, China

Layout table for additonal information
Responsible Party: Xiaoli Fan, Master Degree, West China Hospital
ClinicalTrials.gov Identifier: NCT02936596     History of Changes
Other Study ID Numbers: OS-1
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Undifferentiated Connective Tissue Diseases
Connective Tissue Diseases
Hepatitis
Hepatitis A
Liver Cirrhosis
Cholangitis
Cholestasis
Liver Cirrhosis, Biliary
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Ursodeoxycholic Acid
Immunologic Factors
Physiological Effects of Drugs
Cholagogues and Choleretics
Gastrointestinal Agents