Hepatitis, AutoimmuneNCT02936596
Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
A study testing Ursodeoxycholic acid combination of immunosuppressive agents and Ursodeoxycholic Acid in people with Hepatitis, Autoimmune and Cholangitis, run by Xiaoli Fan at 1 site in China.
Trial summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis, Autoimmune, Cholangitis, Liver Cirrhosis, Biliary
- What is being tested?
- Ursodeoxycholic acid combination of immunosuppressive agents and Ursodeoxycholic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to 1 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- 1.Patients aged 18-70 years;
- 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
- 3.White blood cell count ≥2.5x10^9/L or platelet count ≥50x10^9/L at inclusion;
- 4.Agreed to participate in the trial, and assigned informed consent.
Who cannot join
- 1. The presence of hepatitis A, B, C, D, or E virus infection;
- 2. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.
- 3. Patients with complications of cirrhosis;
- 4. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
- 5. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
- 6. Pregnant and breeding women;
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- 7. Severe disorders of other vital organs, such as severe heart failure, cancer;
- 8. Parenteral administration of blood or blood products within 6 months before screening;
- 9. Recent treatment with drugs having known liver toxicity;
- 10.Taken part in other clinic trials within 6 months before screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Xiaoli Fan, MM, +8618008028017, 13980433451@163.com
Li Yang, MD, yangli_hx@scu.edu.cn
About this study
Official title: Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents
- Being tested
- Ursodeoxycholic acid combination of immunosuppressive agents, Ursodeoxycholic Acid
- Medical subject headings
- Hepatitis, Autoimmune, Cholangitis, Liver Cirrhosis, Biliary, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acid combination of immunosuppressive agentsDrug
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
Ursodeoxycholic AcidDrug
Ursodeoxycholic Acid
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic acid + immunosuppressive agents group | Experimental | Ursodeoxycholic acid + immunosuppressive agents Receives: Drug: Ursodeoxycholic acid combination of immunosuppressive agents |
| Ursodeoxycholic acid group | Active comparator | Ursodeoxycholic acid Receives: Drug: Ursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
Measured: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Secondary outcomes (9)
Alanine transaminase (ALT)
Measured: Week 2 and Month 1, 3, 6
Aspartate transaminase(AST)
Measured: Week 2 and Month 1, 3, 6
Immunoglobulin G(IgG)
Measured: Week 2 and Month 1, 3, 6
Globin(GLB)
Measured: Week 2 and Month 1, 3, 6
Total bilirubin(TB)
Measured: Week 2 and Month 1, 3, 6
Direct bilirubin(DB)
Measured: Week 2 and Month 1, 3, 6
Alkaline phosphatase(ALP)
Measured: Week 2 and Month 1, 3, 6
Glutamyltransferase(GGT)
Measured: Week 2 and Month 1, 3, 6
Side effects
Measured: Evaluation of side effects during the study period(6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, AutoimmuneStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoli Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoli Fan, West China Hospital
- Investigators
- Li Yang, MD, Study chair, West China Hospital,Chengdu, Sichuan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936596
- Sponsor's protocol ID
- OS-1
- Status last verified
- May 2021
- First submitted
- 15 Oct 2016
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents
- ClinicalTrials.gov ID
- NCT02936596
- Acronym / sponsor ID
- OS-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Xiaoli FanUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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.
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic acid + immunosuppressive agents group | Experimental | Drug: Ursodeoxycholic acid combination of immunosuppressive agentsUrsodeoxycholic acid + immunosuppressive agents |
| Ursodeoxycholic acid group | Active comparator | Drug: Ursodeoxycholic AcidUrsodeoxycholic acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Patients aged 18-70 years;
- 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
- 3.White blood cell count ≥2.5x10^9/L or platelet count ≥50x10^9/L at inclusion;
- 4.Agreed to participate in the trial, and assigned informed consent.
Key exclusion criteria (10 listed)
- 1. The presence of hepatitis A, B, C, D, or E virus infection;
- 2. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.
- 3. Patients with complications of cirrhosis;
- 4. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
- 5. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
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 |
|---|---|---|
| Ursodeoxycholic acid combination of immunosuppressive agentsUrsodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine) | Drug | Ursodeoxycholic acid + immunosuppressive agents group |
| Ursodeoxycholic AcidUrsodeoxycholic Acid | Drug | Ursodeoxycholic acid group |
Primary outcome
Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
Time frame: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents
9 secondary outcomes
Alanine transaminase (ALT)
Time frame: Week 2 and Month 1, 3, 6
Aspartate transaminase(AST)
Time frame: Week 2 and Month 1, 3, 6
Immunoglobulin G(IgG)
Time frame: Week 2 and Month 1, 3, 6
Globin(GLB)
Time frame: Week 2 and Month 1, 3, 6
Total bilirubin(TB)
Time frame: Week 2 and Month 1, 3, 6
Direct bilirubin(DB)
Time frame: Week 2 and Month 1, 3, 6
Alkaline phosphatase(ALP)
Time frame: Week 2 and Month 1, 3, 6
Glutamyltransferase(GGT)
Time frame: Week 2 and Month 1, 3, 6
Side effects
Time frame: Evaluation of side effects during the study period(6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Li Yang, MD study chair
West China Hospital,Chengdu, Sichuan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic acid combination of immunosuppressive agents and Ursodeoxycholic Acid in people with Hepatitis, Autoimmune and Cholangitis, run by Xiaoli Fan 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Fan, MM (+862885422311, 13980433451@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH) (time frame: Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents). 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 27 Oct 2021.