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

Autoimmune Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028869
• Other study ID #: DTXY018
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: July 2019
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Liver Disease
• Liver Diseases

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

Locations

Country	Name	City	State
China	liver disease center, Beijing Ditan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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