Autoimmune Liver DiseaseNCT04028869
Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease
An observational study of Autoimmune Liver Disease, run by Beijing Ditan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Liver Disease
- What is being tested?
- Glycyrrhizic acid preparation
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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);
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
liver disease center, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
About this study
Official title: Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment 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.
Read the 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.
- Conditions
- Autoimmune Liver Disease
- Being tested
- Glycyrrhizic acid preparation
- Keywords
- Autoimmune liver disease, glycyrrhizic acid, liver function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycyrrhizic acid preparationDrug
To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment
| Study group | Role | What they receive |
|---|---|---|
| Glycyrrhizin preparation treatment group | Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment Receives: Drug: Glycyrrhizic acid preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 96 weeks and 144 weeks after treatment
Secondary outcomes (1)
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
Measured: at 96 and 144 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Mar 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
- Investigators
- Yao Xie, Doctor, Principal investigator, liver disease center, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028869
- Sponsor's protocol ID
- DTXY018
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment of Autoimmune Liver Disease
- ClinicalTrials.gov ID
- NCT04028869
- Acronym / sponsor ID
- DTXY018
- Conditions
- Autoimmune Liver Disease
- Keywords
- Autoimmune liver disease, glycyrrhizic acid, liver function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycyrrhizin preparation treatment group | – | Drug: Glycyrrhizic acid preparationClinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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);
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycyrrhizic acid preparationTo analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment | Drug | Glycyrrhizin preparation treatment group |
Primary outcome
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
1 secondary outcome
The incidence of decompensated liver cirrhosis and liver cancer and its complications
Time frame: at 96 and 144 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Xie, Doctor principal investigator
liver disease center, Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Liver Disease, run by Beijing Ditan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of sustained biochemical responses (time frame: at 96 weeks and 144 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.