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NCT Number: NCT04028869

Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. The ratio of sustained biochemical responses

    Time frame: 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 outcomes

  1. The incidence of decompensated liver cirrhosis and liver cancer and its complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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