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

Completed

• Conditions: Autoimmune Liver Disease
• Interventions: Drug: Glycyrrhizic acid preparation

• Registration Number: NCT04028869
• Lead Sponsor: Beijing Ditan Hospital

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 Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-20
• Study First Submitted QC: 2019-07-20
• Last Update Submitted: 2019-07-20
• Study First Posted: 2019-07-23
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glycyrrhizin preparation treatment group	Glycyrrhizic acid preparation	Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment

Primary Outcome Measures

Name	Time	Method
The ratio of sustained biochemical responses	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

Name	Time	Method
The incidence of decompensated liver cirrhosis and liver cancer and its complications	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

Trial Locations

Locations (1)

liver disease center, Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China