Hepatitis, AutoimmunePhase 3NCT02878863
Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
A Phase 3 study testing Paeoniflorin + phosphatidylcholine or silymarin and Phosphatidylcholine or silymarin in people with Hepatitis, Autoimmune, run by Xiaoli Fan at 1 site in China.
Trial summary
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatitis, Autoimmune
- What is being tested?
- Paeoniflorin + phosphatidylcholine or silymarin and Phosphatidylcholine or silymarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 2017
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-70 years;
- Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
- High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
- High levels of IgG(1-1.5 X ULN);
- Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
- Agreed to participate in the trial, and assigned informed consent.
Who cannot join
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of liver cirrhosis or portal hypertension;
- Patients with presence of fulminant liver failure;
- Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
- Pregnant and breeding women;
- Severe disorders of other vital organs, such as severe heart failure, cancer;
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- Parenteral administration of blood or blood products within 6 months before screening;
- Recent treatment with drugs having known liver toxicity;
- Taken part in other clinic trials within 6 months before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
- Conditions
- Hepatitis, Autoimmune
- Being tested
- Paeoniflorin + phosphatidylcholine or silymarin, Phosphatidylcholine or silymarin
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paeoniflorin + phosphatidylcholine or silymarinDrug
Also called total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin
Phosphatidylcholine or silymarinDrug
| Study group | Role | What they receive |
|---|---|---|
| Paeoniflorin + phosphatidylcholine or silymarin | Experimental | Paeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin Receives: Drug: Paeoniflorin + phosphatidylcholine or silymarin |
| Phosphatidylcholine or silymarin | Active comparator | Phosphatidylcholine or silymarin Receives: Drug: Phosphatidylcholine or silymarin |
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 AIH
Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits
Measured: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Secondary outcomes (6)
Alanine transaminase (ALT)
Measured: Month 1, 3, 6
Aspartate transaminase(AST)
Measured: Month 1, 3, 6
Immunoglobulin G(IgG)
Measured: Month 1, 3, 6
Globin(GLB)
Measured: Month 1, 3, 6
Total bilirubin(TB)
Measured: Month 1, 3, 6
Direct bilirubin(DB)
Measured: Month 1, 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
- Study completionJul 2017 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT02878863
- Sponsor's protocol ID
- AIH-1
- Status last verified
- Jul 2017
- First submitted
- 9 Aug 2016
- Last updated
- 13 Jul 2017
- 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 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis
- ClinicalTrials.gov ID
- NCT02878863
- Acronym / sponsor ID
- AIH-1
- Conditions
- Hepatitis, Autoimmune
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xiaoli FanUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 Aug 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.
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paeoniflorin + phosphatidylcholine or silymarin | Experimental | Drug: Paeoniflorin + phosphatidylcholine or silymarinPaeoniflorin tablets(600mg, tid)combination of phosphatidylcholine or silymarin |
| Phosphatidylcholine or silymarin | Active comparator | Drug: Phosphatidylcholine or silymarinPhosphatidylcholine or silymarin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 20-70 years;
- Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
- High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
- High levels of IgG(1-1.5 X ULN);
- Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
Key exclusion criteria (9 listed)
- The presence of hepatitis A, B, C, D, or E virus infection;
- Patients with presence of liver cirrhosis or portal hypertension;
- Patients with presence of fulminant liver failure;
- Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
- Pregnant and breeding women;
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 |
|---|---|---|
| Paeoniflorin + phosphatidylcholine or silymarinAlso: total glucosides of paeony(TGP)+ phosphatidylcholine or silymarin | Drug | Paeoniflorin + phosphatidylcholine or silymarin |
| Phosphatidylcholine or silymarin | Drug | Phosphatidylcholine or silymarin |
Primary outcome
Percent of patients that achieve biochemical remission of AIH
Time frame: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits
6 secondary outcomes
Alanine transaminase (ALT)
Time frame: Month 1, 3, 6
Aspartate transaminase(AST)
Time frame: Month 1, 3, 6
Immunoglobulin G(IgG)
Time frame: Month 1, 3, 6
Globin(GLB)
Time frame: Month 1, 3, 6
Total bilirubin(TB)
Time frame: Month 1, 3, 6
Direct bilirubin(DB)
Time frame: Month 1, 3, 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- 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 Phase 3 study testing Paeoniflorin + phosphatidylcholine or silymarin and Phosphatidylcholine or silymarin in people with Hepatitis, Autoimmune, 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 6 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: withdrawn, as of the sponsor's last update on 13 Jul 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent of patients that achieve biochemical remission of AIH (time frame: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only). 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 13 Jul 2017.