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出境医 / 临床实验 / Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease

Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease

Study Description
Brief Summary:
This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

Condition or disease Intervention/treatment
Autoimmune Liver Disease Drug: Glycyrrhizic acid preparation

Detailed Description:
This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment of Autoimmune Liver Disease
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
Glycyrrhizin preparation treatment group
Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment
 Drug: Glycyrrhizic acid preparation
To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment
Outcome Measures
Primary Outcome Measures :
  1. The ratio of sustained biochemical responses [ Time Frame: at 96 weeks and 144 weeks after treatment ]
    The ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease


Secondary Outcome Measures :
  1. The incidence of decompensated liver cirrhosis and liver cancer and its complications [ Time Frame: at 96 and 144 weeks after treatment ]
    The incidence of decompensated liver cirrhosis and liver cancer and its complications at 96 and 144 weeks after treatment with glycyrrhizic acid in patients with autoimmune liver disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);
Criteria

Inclusion Criteria:

  • 1) Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);
  • 2) no hormones and / or immunosuppressants and other liver protection drugs;
  • 3) Sign the written informed consent form.

Exclusion Criteria:

  • 1) Combine other hepatitis virus (HCV, HDV) infections;
  • 2) viral liver disease;
  • 3) HIV infection;
  • 4) long-term alcohol abuse and / or other liver damage drugs;
  • 5) mental illness;
  • 6) Evidence of liver tumors (liver cancer or AFP > 100 ng/ml);
  • 7) decompensated cirrhosis;
  • 8) Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up;
  • 9) There are hormones and / or immunosuppressants and other liver protection drugs.
Contacts and Locations

Locations
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China, Beijing
liver disease center, Beijing Ditan Hospital
Beijing, Beijing, China, 100015
Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
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Principal Investigator: Yao Xie, Doctor liver disease center, Beijing Ditan Hospital
Tracking Information
First Submitted Date July 20, 2019
First Posted Date July 23, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date March 1, 2018
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2019) 		The ratio of sustained biochemical responses [ Time Frame: at 96 weeks and 144 weeks after treatment ]
The ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 20, 2019) 		The incidence of decompensated liver cirrhosis and liver cancer and its complications [ Time Frame: at 96 and 144 weeks after treatment ]
The incidence of decompensated liver cirrhosis and liver cancer and its complications at 96 and 144 weeks after treatment with glycyrrhizic acid in patients with autoimmune liver disease
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease
Official Title Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment of Autoimmune Liver Disease
Brief Summary This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.
Detailed Description This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);
Condition Autoimmune Liver Disease
Intervention Drug: Glycyrrhizic acid preparation
To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment
Study Groups/Cohorts Glycyrrhizin preparation treatment group
Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment
Intervention: Drug: Glycyrrhizic acid preparation
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 Completed
Actual Enrollment
 (submitted: July 20, 2019) 		400
Original Actual Enrollment Same as current
Actual Study Completion Date March 30, 2019
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1) Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);
  • 2) no hormones and / or immunosuppressants and other liver protection drugs;
  • 3) Sign the written informed consent form.

Exclusion Criteria:

  • 1) Combine other hepatitis virus (HCV, HDV) infections;
  • 2) viral liver disease;
  • 3) HIV infection;
  • 4) long-term alcohol abuse and / or other liver damage drugs;
  • 5) mental illness;
  • 6) Evidence of liver tumors (liver cancer or AFP > 100 ng/ml);
  • 7) decompensated cirrhosis;
  • 8) Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up;
  • 9) There are hormones and / or immunosuppressants and other liver protection drugs.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04028869
Other Study ID Numbers DTXY018
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yao Xie, Beijing Ditan Hospital
Study Sponsor Beijing Ditan Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yao Xie, Doctor liver disease center, Beijing Ditan Hospital
PRS Account Beijing Ditan Hospital
Verification Date July 2019

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