Clinical trial NCT04028869: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Liver Disease
Keywords: Autoimmune liver disease
glycyrrhizic acid
liver function
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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);

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.

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.

Primary outcomes:
measure: The ratio of sustained biochemical responses
timeFrame: at 96 weeks and 144 weeks after treatment
Secondary outcomes:
measure: The incidence of decompensated liver cirrhosis and liver cancer and its complications
timeFrame: at 96 and 144 weeks after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: liver disease center, Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: liver disease center, Beijing Ditan Hospital
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References: