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

Primary Purpose

Acute Drug Induced Liver Injury

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Polyene phosphatidylcholine injection 930 mg QD
Magnesium Isoglycyrrhizinate injection 200 mg QD
Sponsored by
Sichuan Haisco Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Drug Induced Liver Injury focused on measuring ADILI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Second Hospital of Anhui Medical University
  • Beijing Chest Hospital of Capital Medical University
  • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Shenzhen People's Hospital
  • The Sixth People's Hospital of Zhengzhou
  • The Third Hospital of Zhenjiang Affiliated Jiangsu University
  • Renji Hospital
  • Shanghai Pulmonary Hospital
  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Polyene Phosphatidylcholine

Magnesium Isoglycyrrhizinate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The serum ALT normalization rate for 1, 2 and 3 weeks
Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks
The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks
The serum AST normalization rate for 1, 2, 3 and 4 weeks
Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks
The serum TBIL normalization rate for 1, 2, 3 and 4 weeks
Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks
Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks
The Incidence of Treatment-Emergent Adverse Events over time

Full Information

First Posted
October 14, 2020
Last Updated
November 22, 2020
Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04595916
Brief Title
Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
Official Title
A Multicenter, Randomized, Single-blind, Active-controlled Trial of The Efficacy and Safety of Polyene Phosphatidylcholine in Patients With Acute Drug-induced Liver Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2020 (Actual)
Primary Completion Date
October 21, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is a phase IV study in subjects with acute drug-induced liver injury. As designed, the study will include a screening period of up to 1 week, 2 to 4 weeks of treatment, and 1 week of safety follow-up. The eligible subjects will randomly be assigned to polyene phosphatidylcholine group or magnesium isoglycyrrhizinate group to receive single-blind treatment with a ratio of 1:1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Drug Induced Liver Injury
Keywords
ADILI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyene Phosphatidylcholine
Arm Type
Experimental
Arm Title
Magnesium Isoglycyrrhizinate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Polyene phosphatidylcholine injection 930 mg QD
Intervention Description
Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Magnesium Isoglycyrrhizinate injection 200 mg QD
Intervention Description
Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
Primary Outcome Measure Information:
Title
Serum ALT normalization rate
Description
The serum ALT normalization rate of treatment for 2-4 weeks
Time Frame
After 2-4 weeks treatment
Secondary Outcome Measure Information:
Title
The serum ALT normalization rate for 1, 2 and 3 weeks
Time Frame
After 1, 2 and 3 weeks treatment
Title
Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
The serum AST normalization rate for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
The serum TBIL normalization rate for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks
Time Frame
After 1, 2, 3 and 4 weeks treatment
Title
The Incidence of Treatment-Emergent Adverse Events over time
Time Frame
After 2 to 4 weeks of treatment and 1 week of safety follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yimin Mao, M.D.
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Chest Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Mengchao Hepatobiliary Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The Sixth People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Third Hospital of Zhenjiang Affiliated Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tongji Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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