Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury

NCT04595916 | Completed Phase 4

• 1 other identifier: HSK-28-201
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to explore the efficacy and the safety of polyene phosphatidylcholine Injection in patients with acute drug-induced liver injury after 2-4 weeks of treatment.

Conditions

Acute Drug Induced Liver Injury

Keywords

ADILI

Outcome Measures

Primary Outcomes (1)

• Serum ALT normalization rate

  The serum ALT normalization rate of treatment for 2-4 weeks

  After 2-4 weeks treatment

Secondary Outcomes (9)

• The serum ALT normalization rate for 1, 2 and 3 weeks

  After 1, 2 and 3 weeks treatment

• Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks

  After 1, 2, 3 and 4 weeks treatment

• The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks

  After 1, 2, 3 and 4 weeks treatment

• The serum AST normalization rate for 1, 2, 3 and 4 weeks

  After 1, 2, 3 and 4 weeks treatment

• Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks

  After 1, 2, 3 and 4 weeks treatment

Study Arms (2)

Polyene Phosphatidylcholine

EXPERIMENTAL

Drug: Polyene phosphatidylcholine injection 930 mg QD

Magnesium Isoglycyrrhizinate

ACTIVE COMPARATOR

Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD

Interventions

Polyene phosphatidylcholine injection 930 mg QD DRUG

Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.

Polyene Phosphatidylcholine

Magnesium Isoglycyrrhizinate injection 200 mg QD DRUG

Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.

Magnesium Isoglycyrrhizinate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years, Male or female patients
• Alanine aminotransferase (ALT) ≥ 3 x upper limit of normal (ULN) and Total bilirubin (TBIL) ≤ 5 x upper limit of normal (ULN)
• The Roussel Uclaf Causality Assessment Method (RUCAM) score is more than or equal to 6 points. The patients with RUCAM score of 3-5 needs to be determined by all three investigators that the liver injury is likely to be caused by drugs
• The duration of the current liver injury does not exceed 6 months

You may not qualify if:

• Liver injury caused by other diseases, such as viral hepatitis, alcoholic and non-alcoholic fatty liver disease, or autoimmune liver disease
• Acute liver failure or liver function decompensation, such as hepatic encephalopathy, ascites, albumin is less than 35g / L, the international standardized ratio (INR) of thrombin is more than 1.5
• Anemia or thrombocytopenia, hemoglobin is below 80 g/L, platelet count below 50,000 platelets per microliter
• Serum creatinine is more than 1.5 times ULN
• Severe hypokalemia, severe hypernatremia
• Patients have severe uncontrolled hypertension
• Severe diseases of vital organs such as heart, lung, brain, kidney, and gastrointestinal tract
• Treatment with polyene phosphatidylcholine injection or magnesium isoglycyrrhizinate injection within 5 days before informed consent
• Allergy or intolerance to benzyl alcohol and study drugs
• With no ability to express their complaints, such as mental illness and severe neurosis patient
• Pregnant or breastfeeding women, fertile women or men are reluctant to use contraception to avoid pregnancy during the trial
• Participation in another trial within 3 months before informed consent
• Patients who are considered by the investigator as inappropriate for the trial for other reasons

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (9)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Chest Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Location

The Third Hospital of Zhenjiang Affiliated Jiangsu University

Zhenjiang, Jiangsu, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

Tongji Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

polyene phosphatidylcholine; 18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate

Condition Hierarchy (Ancestors)

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

Study Officials

• Yimin Mao, M.D.

  RenJi Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: April 4, 2020
• Primary Completion: October 21, 2020
• Study Completion: November 2, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)