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

NCT04028869 | Completed

• 1 other identifier: DTXY018
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Liver Disease

Keywords

Autoimmune liver disease; glycyrrhizic acid; liver function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence of decompensated liver cirrhosis and liver cancer and its complications

  at 96 and 144 weeks after treatment

Study Arms (1)

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

Interventions

Glycyrrhizic acid preparation DRUG

To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment

Glycyrrhizin preparation treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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);

You may qualify if:

• \) 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);
• \) no hormones and / or immunosuppressants and other liver protection drugs;
• \) Sign the written informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

Location

Study Officials

• Yao Xie, Doctor

  liver disease center, Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Second Division of Liver Diseases

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 23, 2019
• Study Start: March 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)