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 Treatment of Autoimmune Liver Disease

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 Overview

• Status: Completed
• Conditions: Autoimmune Liver Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • liver disease center, Beijing Ditan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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);

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio of sustained biochemical responses	The ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease	at 96 weeks and 144 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of decompensated liver cirrhosis and liver cancer and its complications	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	at 96 and 144 weeks after treatment

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital
• Investigators: Principal Investigator: Yao Xie, Doctor, liver disease center, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): March 30, 2019

Study Registration Dates

• First Submitted: July 20, 2019
• First Submitted That Met QC Criteria: July 20, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: liver function; Autoimmune liver disease; glycyrrhizic acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Anti-Inflammatory Agents; Glycyrrhizic Acid
• Other Study ID Numbers: DTXY018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No