Drug-Induced Liver InjuryPPC-HM-DILINCT07476885
A Real World Study of Polyene Phosphatidylcholine Injection for the Prevention and Treatment of DILI in Patients With Malignant Hematological Diseases
An observational study of Drug-Induced Liver Injury, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Induced Liver Injury
- What is being tested?
- polyene phosphatidylcholine
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 31 Jan 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with drug-induced liver injury caused by malignant hematological diseases who received treatment that met the inclusion criteria of this study
Who may be able to join
- Over 18 years old, gender not limited;
- Confirmed by histology or cytology as malignant hematological diseases (including but not limited to acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma);
- Patients who have received at least one cycle of chemotherapy regimens with a clear risk of hepatotoxicity;
- Receive treatment with polyene phosphatidylcholine injection or prevent liver injury;
- Liver injury treatment drugs are used in combination, and drugs containing the following are used in combination with polyene phosphatidylcholine injection. The combined use of drugs includes one or both of magnesium isoglycyrrhizinate injection, glutathione injection, adenosylmethionine succinate injection/tablet, ursodeoxycholic acid oral preparation, and bicyclol alcohol tablets. In addition, those who have not used other liver-protecting drugs;
- Those who have at least one record of liver function test within 7 days before and after the application of liver injury treatment drugs.
Who cannot join
- Patients with significantly missing main research data, including age, gender, liver function indicators (ALT/AST/TBIL) before and after treatment, and important information related to disease diagnosis and treatment;
- For active viral hepatitis, autoimmune liver disease, alcoholic or non-alcoholic fatty liver disease, etc., identify other major causes of liver damage;
- Those who have used drugs with therapeutic effects on liver damage one week before treatment; Other researchers determine those who affect the evaluation of therapeutic effects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe.
It also aims to answer these key questions:
Read more
Does Polyene Phosphatidylcholine Injection help prevent DILI in people with hematologic malignancies? How effective and safe are different combinations of Polyene Phosphatidylcholine Injection with other liver-protective drugs for DILI? Which DILI treatment plan offers better value for money?
Who can take part?
Participants must meet all these criteria:
18 years or older (no gender restriction) Diagnosed with a hematologic malignancy (such as leukemia, lymphoma, or multiple myeloma) Received at least one cycle of chemotherapy that may harm the liver Used Polyene Phosphatidylcholine Injection to treat or prevent DILI (alone or with one/two specific liver-protective drugs: Magnesium Isoglycyrrhizinate Injection, Glutathione Injection, Ademetionine 1,4-Butanedisulfonate Injection/Tablets, Ursodeoxycholic Acid Oral Formulation, or Bicyclol Tablets) Had liver function tests within 7 days before starting treatment and at least once after starting treatment
What will the study involve?
Researchers will look back at medical records of eligible participants treated on or before November 30, 2025. They will collect and analyze:
Participants' basic information (age, gender) and disease details Details about Polyene Phosphatidylcholine Injection use (dose, frequency, duration) Liver function test results (including alanine aminotransferase [ALT, a liver enzyme that rises when the liver is injured], aspartate aminotransferase [AST], total bilirubin [TBIL], and other related indicators) at different time points (3 days, 7 days, 14 days, 21 days, 30 days, 60 days) after starting treatment Any unwanted health issues (adverse events, AEs) during treatment and how they were managed Costs related to treatment (drug fees, test fees, AE management fees)
What are the key things researchers will measure? Main measure: How well ALT levels improve 7 days after starting Polyene Phosphatidylcholine Injection (defined as ALT dropping by more than 50% or returning to normal)
Secondary measures:
Improvement in liver function indicators at other time points (3 days, 14 days, 21 days, 30 days, 60 days) How well the drug prevents DILI (how often DILI occurs and how severe it is) Differences in effectiveness and safety between different drug combinations Which treatment plan is more cost-effective
- Conditions
- Drug-Induced Liver Injury
- Being tested
- polyene phosphatidylcholine
- Keywords
- PPC, DILI
- 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.
polyene phosphatidylcholineDrug
Also called PPC
The clinical visit data of patients with malignant hematological diseases who used polyene phosphatidylcholine injection for the prevention or treatment of drug-induced liver injury were retrospectively collected
What is being measured
The primary outcome is the main question the study is designed to answer.
The effective rate of ALT treatment 7 days after the initiation of polyene phosphatidylcholine
defined as the proportion of ALT reduction > 50% + recovery rate
Measured: From enrollment to the end of treatment at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (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 Hematology & Blood Diseases Hospital, ChinaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476885
- Sponsor's protocol ID
- QT2025012
- Acronym
- PPC-HM-DILI
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Polyene Phosphatidylcholine Injection for the Prevention and Treatment of DILI in Patients With Malignant Hematological Diseases
- ClinicalTrials.gov ID
- NCT07476885
- Acronym / sponsor ID
- PPC-HM-DILI / QT2025012
- Conditions
- Drug-Induced Liver Injury
- Keywords
- PPC, DILI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Mar 2026 (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.
This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe.
It also aims to answer these key questions:
Does Polyene Phosphatidylcholine Injection help prevent DILI in people with hematologic malignancies? How effective and safe are different combinations of Polyene Phosphatidylcholine Injection with other liver-protective drugs for DILI? Which DILI treatment plan offers better value for money?
Who can take part?
Participants must meet all these criteria:
18 years or older (no gender restriction) Diagnosed with a hematologic malignancy (such as leukemia, lymphoma, or multiple myeloma) Received at least one cycle of chemotherapy that may harm the liver Used Polyene Phosphatidylcholine Injection to treat or prevent DILI (alone or with one/two specific liver-protective drugs: Magnesium Isoglycyrrhizinate Injection, Glutathione Injection, Ademetionine 1,4-Butanedisulfonate Injection/Tablets, Ursodeoxycholic Acid Oral Formulation, or Bicyclol Tablets) Had liver function tests within 7 days before starting treatment and at least once after starting treatment
What will the study involve?
Researchers will look back at medical records of eligible participants treated on or before November 30, 2025. They will collect and analyze:
Participants' basic information (age, gender) and disease details Details about Polyene Phosphatidylcholine Injection use (dose, frequency, duration) Liver function test results (including alanine aminotransferase [ALT, a liver enzyme that rises when the liver is injured], aspartate aminotransferase [AST], total bilirubin [TBIL], and other related indicators) at different time points (3 days, 7 days, 14 days, 21 days, 30 days, 60 days) after starting treatment Any unwanted health issues (adverse events, AEs) during treatment and how they were managed Costs related to treatment (drug fees, test fees, AE management fees)
What are the key things researchers will measure? Main measure: How well ALT levels improve 7 days after starting Polyene Phosphatidylcholine Injection (defined as ALT dropping by more than 50% or returning to normal)
Secondary measures:
Improvement in liver function indicators at other time points (3 days, 14 days, 21 days, 30 days, 60 days) How well the drug prevents DILI (how often DILI occurs and how severe it is) Differences in effectiveness and safety between different drug combinations Which treatment plan is more cost-effective
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with drug-induced liver injury caused by malignant hematological diseases who received treatment that met the inclusion criteria of this study
Key inclusion criteria (6 listed)
- Over 18 years old, gender not limited;
- Confirmed by histology or cytology as malignant hematological diseases (including but not limited to acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma);
- Patients who have received at least one cycle of chemotherapy regimens with a clear risk of hepatotoxicity;
- Receive treatment with polyene phosphatidylcholine injection or prevent liver injury;
- Liver injury treatment drugs are used in combination, and drugs containing the following are used in combination with polyene phosphatidylcholine injection. The combined use of drugs includes one or both of magnesium isoglycyrrhizinate injection, glutathione injection, adenosylmethionine succinate injection/tablet, ursodeoxycholic acid oral preparation, and bicyclol alcohol tablets. In addition, those who have not used other liver-protecting drugs;
Key exclusion criteria (3 listed)
- Patients with significantly missing main research data, including age, gender, liver function indicators (ALT/AST/TBIL) before and after treatment, and important information related to disease diagnosis and treatment;
- For active viral hepatitis, autoimmune liver disease, alcoholic or non-alcoholic fatty liver disease, etc., identify other major causes of liver damage;
- Those who have used drugs with therapeutic effects on liver damage one week before treatment; Other researchers determine those who affect the evaluation of therapeutic effects.
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 |
|---|---|---|
| polyene phosphatidylcholineAlso: PPCThe clinical visit data of patients with malignant hematological diseases who used polyene phosphatidylcholine injection for the prevention or treatment of drug-induced liver injury were retrospectively collected | Drug | – |
Primary outcome
The effective rate of ALT treatment 7 days after the initiation of polyene phosphatidylcholine
Time frame: From enrollment to the end of treatment at 7 days
defined as the proportion of ALT reduction > 50% + recovery rate
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 17 Mar 2026.
Related trials for Drug-Induced Liver Injury
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
Drug-Induced Acute Liver Injury, Tuberculosis (TB)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingPhase 3
Misocholic Tablets for Non-Viral Elevated Liver Enzymes
Alcohol-Related Liver Disease, Drug-Induced Liver Injury
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-Induced Liver Injury, run by Institute of Hematology & Blood Diseases Hospital, 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 3 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 wei hua Zhai (022-23608567, zhaiweihua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effective rate of ALT treatment 7 days after the initiation of polyene phosphatidylcholine (time frame: From enrollment to the end of treatment at 7 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 17 Mar 2026.