A Real World Study of Polyene Phosphatidylcholine Injection for the Prevention and Treatment of DILI in Patients With Malignant Hematological Diseases (PPC-HM-DILI)

March 12, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with drug-induced liver injury caused by malignant hematological diseases who received treatment that met the inclusion criteria of this study

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QT2025012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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