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

NCT07476885 | Not Yet Recruiting

• 1 other identifier: QT2025012
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Drug-Induced Liver Injury

Keywords

PPC; DILI

Outcome Measures

Primary Outcomes (1)

• The effective rate of ALT treatment 7 days after the initiation of polyene phosphatidylcholine

  defined as the proportion of ALT reduction \> 50% + recovery rate

  From enrollment to the end of treatment at 7 days

Interventions

polyene phosphatidylcholine DRUG

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

Also known as: PPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

polyene phosphatidylcholine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Central Study Contacts

wei hua Zhai

CONTACT

022-23608567; zhaiweihua@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: March 17, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03