Drug Induced Liver InjuryPhase 2/3NCT06797011
Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease
A Phase 2/3 study testing High volume Plasma Exchange and Standard Medical Treatment in people with Drug Induced Liver Injury and Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug Induced Liver Injury, Chronic Liver Disease
- What is being tested?
- High volume Plasma Exchange and Standard Medical Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jan 2025to 31 Jan 2026
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years with previously known or unknown underlying CLD.
- Diagnosis of DILI based causality of assessment by RECAM.
- Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl.
- Consent to participate in the study (based on biopsy/imaging/or clinical criteria).
Who cannot join
- Active infection
- Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).
- Pregnant or breastfeeding women.
- HCC or any malignancy
- UGI bleed, uncontrolled HE
- Option LTx being considered
Show all 9Show fewer
- S. Creatinine > 2mg/dL
- DILI ALF
- Alcoholic Hepatitis
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 Khushboo Yadav, MD, 01146300000, ky29277@gmail.com
About this study
Official title: Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT
DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease.
Asia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.
Read the detailed description
Study Design Single-center, non-blinded, parallel group, randomized controlled trial. Allocation ratio between two groups: 1:1.
Study population: Adults aged 18-75 years with previously known or unknown underlying CLD Diagnosis of DILI-based causality of assessment by RECAM. Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl Consent to participate in the study (based on biopsy, imaging or clinical criteria).
Study design: RCT Study period: 1 year Sample size: 96 Intervention: Patients after screening for all exclusion criteria will be randomized into either the standard treatment group or the plasma exchange group.
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.
- Conditions
- Drug Induced Liver Injury, Chronic Liver Disease
- Being tested
- High volume Plasma Exchange, Standard Medical Treatment
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High volume Plasma ExchangeBiological
High volume Plasma Exchange with minimum 3 sessions on alternate days
Standard Medical TreatmentOther
Standard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH
| Study group | Role | What they receive |
|---|---|---|
| PLEX with SMT | Experimental | High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment. Receives: Biological: High volume Plasma Exchange; Other: Standard Medical Treatment |
| Standard Medical Treatment | Active comparator | Standard treatment. Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Transplant free survival at the end of 30 days between two groups.
Measured: 30 days
Secondary outcomes (5)
Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days
Measured: 0, 3, 5 days
Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.
Measured: 0 and 30 day.
Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day.
Measured: 0 and 30 day.
Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.
Measured: 0, 3, 5,30, and 90 days.
Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.
Measured: 0, 3, 5,30 and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start25 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induced Liver InjuryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 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
- NCT06797011
- Sponsor's protocol ID
- ILBS-DILI-01
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT
- ClinicalTrials.gov ID
- NCT06797011
- Acronym / sponsor ID
- ILBS-DILI-01
- Conditions
- Drug Induced Liver Injury, Chronic Liver Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 Jan 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.
DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease.
Asia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.
Detailed description
Study Design Single-center, non-blinded, parallel group, randomized controlled trial. Allocation ratio between two groups: 1:1.
Study population: Adults aged 18-75 years with previously known or unknown underlying CLD Diagnosis of DILI-based causality of assessment by RECAM. Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl Consent to participate in the study (based on biopsy, imaging or clinical criteria).
Study design: RCT Study period: 1 year Sample size: 96 Intervention: Patients after screening for all exclusion criteria will be randomized into either the standard treatment group or the plasma exchange group.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLEX with SMT | Experimental | Biological: High volume Plasma Exchange, Other: Standard Medical TreatmentHigh Volume Plex with minimum 3 sessions on alternate days along with Standard treatment. |
| Standard Medical Treatment | Active comparator | Other: Standard Medical TreatmentStandard treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-75 years with previously known or unknown underlying CLD.
- Diagnosis of DILI based causality of assessment by RECAM.
- Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl.
- Consent to participate in the study (based on biopsy/imaging/or clinical criteria).
Key exclusion criteria (9 listed)
- Active infection
- Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).
- Pregnant or breastfeeding women.
- HCC or any malignancy
- UGI bleed, uncontrolled HE
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 |
|---|---|---|
| High volume Plasma ExchangeHigh volume Plasma Exchange with minimum 3 sessions on alternate days | Biological | PLEX with SMT |
| Standard Medical TreatmentStandard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH | Other | PLEX with SMT, Standard Medical Treatment |
Primary outcome
Liver Transplant free survival at the end of 30 days between two groups.
Time frame: 30 days
5 secondary outcomes
Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days
Time frame: 0, 3, 5 days
Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.
Time frame: 0 and 30 day.
Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day.
Time frame: 0 and 30 day.
Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.
Time frame: 0, 3, 5,30, and 90 days.
Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.
Time frame: 0, 3, 5,30 and 90 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 28 Jan 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 Phase 2/3 study testing High volume Plasma Exchange and Standard Medical Treatment in people with Drug Induced Liver Injury and Chronic Liver Disease, 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 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: opening soon, as of the sponsor's last update on 28 Jan 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 Khushboo Yadav, MD (01146300000, ky29277@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Transplant free survival at the end of 30 days between two groups. (time frame: 30 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 28 Jan 2025.