Hepatitis, AutoimmuneNCT02874586
Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis
A study testing Plasma exchange combination of immunosuppressive regimens in people with Hepatitis, Autoimmune, run by Xiaoli Fan at 1 site in China.
Trial summary
An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis, Autoimmune
- What is being tested?
- Plasma exchange combination of immunosuppressive regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Sep 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy;
- High levels of total bilirubin (TB) (≥10 X ULN);
- High levels of immunoglobulin G(IgG) (≥1.5 X ULN);
- 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;
- Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
- Pregnant and breeding women;
- Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 2500/mm3), or thrombocytopenia (platelet count < 50,000/mm3);
- 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.
Xiaoli Fan, MM contact
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Li Yang, MD, +8618980601276, yangli_hx@scu.edu.cn
About this study
Official title: Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis
An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).
- Conditions
- Hepatitis, Autoimmune
- Being tested
- Plasma exchange combination of immunosuppressive regimens
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchange combination of immunosuppressive regimensOther
| Study group | Role | What they receive |
|---|---|---|
| Plasma exchange combination of immunosuppressive regimens | Experimental | Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis Receives: Other: Plasma exchange combination of immunosuppressive regimens |
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
Measured: Month 6 after the treatment initiated
Secondary outcomes (6)
Alanine transaminase (ALT)
Measured: Day 1, and Week 1, 2, 4, 12, 24
Aspartate transaminase(AST)
Measured: Day 1, and Week 1, 2, 4, 12, 24
Globin(GLB)
Measured: Day 1, and Week 1, 2, 4, 12, 24
Immunoglobulin G(IgG)
Measured: Day 1, and Week 1, 2, 4, 12, 24
Total bilirubin(TB)
Measured: Day 1, and Week 1, 2, 4, 12, 24
Direct bilirubin(DB)
Measured: Day 1, and Week 1, 2, 4, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2021 (estimated)
- Study completionSep 2021 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02874586
- Sponsor's protocol ID
- AIH-2
- Status last verified
- Nov 2020
- First submitted
- 17 Aug 2016
- Last updated
- 10 Nov 2020
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis
- ClinicalTrials.gov ID
- NCT02874586
- Acronym / sponsor ID
- AIH-2
- Conditions
- Hepatitis, Autoimmune
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiaoli FanUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 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,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma exchange combination of immunosuppressive regimens | Experimental | Other: Plasma exchange combination of immunosuppressive regimensPlasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy;
- High levels of total bilirubin (TB) (≥10 X ULN);
- High levels of immunoglobulin G(IgG) (≥1.5 X ULN);
- Agreed to participate in the trial, and assigned informed consent;
Key exclusion criteria (9 listed)
- The presence of hepatitis A, B, C, D, or E virus infection;
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 |
|---|---|---|
| Plasma exchange combination of immunosuppressive regimens | Other | Plasma exchange combination of immunosuppressive regimens |
Primary outcome
Percent of patients that achieve biochemical remission of AIH
Time frame: Month 6 after the treatment initiated
6 secondary outcomes
Alanine transaminase (ALT)
Time frame: Day 1, and Week 1, 2, 4, 12, 24
Aspartate transaminase(AST)
Time frame: Day 1, and Week 1, 2, 4, 12, 24
Globin(GLB)
Time frame: Day 1, and Week 1, 2, 4, 12, 24
Immunoglobulin G(IgG)
Time frame: Day 1, and Week 1, 2, 4, 12, 24
Total bilirubin(TB)
Time frame: Day 1, and Week 1, 2, 4, 12, 24
Direct bilirubin(DB)
Time frame: Day 1, and Week 1, 2, 4, 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- 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.
Xiaoli Fan, MM contact
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 Plasma exchange combination of immunosuppressive regimens 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 4 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: status not confirmed, as of the sponsor's last update on 10 Nov 2020. 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), 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 AIH (time frame: Month 6 after the treatment initiated). 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 10 Nov 2020.