Autoimmune HepatitisNCT06855667
Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis.
A study testing Plasma Exchange, Steroid and Diet in people with Autoimmune Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Plasma Exchange, Steroid and Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 3 Mar 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Acute severe autoimmune hepatitis with MELD >24
- No liver transplant option < 28 days.
- -ACLF + Non ACLF
- Auto immune hepatitis: Diagnosis by simplified AIH score ≥6
Who cannot join
- Patients with Active sepsis
- Patients with Active bleeding
- Patients allergic to FFP and blood products
- Patients with unstable hemodynamics ( eg:BP<90/60 mmhg,HR >100bpm)
- Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- Pregnancy related liver failure
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- Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
- Refusal to participate in the study
- Patients who are eligible to transplant
- Patients who received steroids or on steroids last 7 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr J.Gnana Kavitha, MD, 01146300000, drkavitha777@gmail.com
About this study
Official title: Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis: A Pilot Randomized Controlled Study
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.
Read the detailed description
- Study population: Patients presenting with severe autoimmune hepatitis and MELD>24 with no liver transplant option.
- Study design: A Pilot Randomised control trial
- Study period: 2 year
- Sample size:
- There is no studies of PE in severe AIH, assuming effect of PE in ACLF group
- Survival rate with plasma exchange was assumed to be 60 % and 20 % without PE.
- Further assuming 95% power and alpha 5 %.
- We need to enroll 46 cases i.e. 23 in each group
- Further assuming % defaulter rate, it is further decided to enroll 25 cases in each group.
- Patients will be randomly allocated in 2 groups by 1:1 block randomisation and will be implemented by IWRS facility taking block size 10.
- Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid.
- Interim analysis would be done to check efficacy and safety of TPE in severe autoimmune hepatitis.
- Adverse effects:
Therapeutic Plasma Exchange is associated with risk of adverse events like infections,Fluid overload or circulatory insufficiency, Hypersensitivity to blood products.
- Stopping rule: Study will be stopped in case of life- threatening events occur in patient after randomisation
- Conditions
- Autoimmune Hepatitis
- Being tested
- Plasma Exchange, Steroid, Diet
- 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 ExchangeBiological
3 to 5 sessions alternate day
SteroidDrug
Steroid
DietDietary supplement
Diet
| Study group | Role | What they receive |
|---|---|---|
| Plasma Exchange | Experimental | 3 to 5 sessions +Steroids Receives: Biological: Plasma Exchange; Drug: Steroid |
| Standard Medical Treatment | Active comparator | Steroids + Nutrition Receives: Drug: Steroid; Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with change in AST,ALT,Bilirubin
Measured: 28 days
Secondary outcomes (7)
Liver transplant free survival at 28 days.
Measured: 28 days
Development of adverse event due to TPE
Measured: 28 days
Number of patients with development of clinical infection during study period
Clinical infections includes pneumonia, SBP,UTI,soft tissue infections,blood stream infections.
Measured: 28 days
Mortality during hospital stay
Measured: 28 days
Change in grade of HE, grade of ascites (both ascites and HE if present).
Measured: 28 days
Frequency of decompensation events on follow up period.
Measured: 28 days
Infections at 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start3 Mar 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855667
- Sponsor's protocol ID
- ILBS-AIH-02
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis: A Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06855667
- Acronym / sponsor ID
- ILBS-AIH-02
- Conditions
- Autoimmune Hepatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 4 Mar 2025 (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.
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.
Detailed description
- Study population: Patients presenting with severe autoimmune hepatitis and MELD>24 with no liver transplant option.
- Study design: A Pilot Randomised control trial
- Study period: 2 year
- Sample size:
- There is no studies of PE in severe AIH, assuming effect of PE in ACLF group
- Survival rate with plasma exchange was assumed to be 60 % and 20 % without PE.
- Further assuming 95% power and alpha 5 %.
- We need to enroll 46 cases i.e. 23 in each group
- Further assuming % defaulter rate, it is further decided to enroll 25 cases in each group.
- Patients will be randomly allocated in 2 groups by 1:1 block randomisation and will be implemented by IWRS facility taking block size 10.
- Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid.
- Interim analysis would be done to check efficacy and safety of TPE in severe autoimmune hepatitis.
- Adverse effects:
Therapeutic Plasma Exchange is associated with risk of adverse events like infections,Fluid overload or circulatory insufficiency, Hypersensitivity to blood products.
- Stopping rule: Study will be stopped in case of life- threatening events occur in patient after randomisation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma Exchange | Experimental | Biological: Plasma Exchange, Drug: Steroid3 to 5 sessions +Steroids |
| Standard Medical Treatment | Active comparator | Drug: Steroid, Dietary Supplement: DietSteroids + Nutrition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years
- Acute severe autoimmune hepatitis with MELD >24
- No liver transplant option < 28 days.
- -ACLF + Non ACLF
- Auto immune hepatitis: Diagnosis by simplified AIH score ≥6
Key exclusion criteria (10 listed)
- Patients with Active sepsis
- Patients with Active bleeding
- Patients allergic to FFP and blood products
- Patients with unstable hemodynamics ( eg:BP<90/60 mmhg,HR >100bpm)
- Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
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 Exchange3 to 5 sessions alternate day | Biological | Plasma Exchange |
| SteroidSteroid | Drug | Plasma Exchange, Standard Medical Treatment |
| DietDiet | Dietary supplement | Standard Medical Treatment |
Primary outcome
Number of patients with change in AST,ALT,Bilirubin
Time frame: 28 days
7 secondary outcomes
Liver transplant free survival at 28 days.
Time frame: 28 days
Development of adverse event due to TPE
Time frame: 28 days
Number of patients with development of clinical infection during study period
Time frame: 28 days
Mortality during hospital stay
Time frame: 28 days
Change in grade of HE, grade of ascites (both ascites and HE if present).
Time frame: 28 days
Frequency of decompensation events on follow up period.
Time frame: 28 days
Infections at 28 days
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- 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.
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, Steroid and Diet in people with Autoimmune Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 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: opening soon, as of the sponsor's last update on 4 Mar 2025. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr J.Gnana Kavitha, MD (09717270640, drkavitha777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with change in AST,ALT,Bilirubin (time frame: 28 days). 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 4 Mar 2025.