Trials Sponsors Conditions Drugs Pricing

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
+4 more secondary outcomes

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 QDDrug

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 QDDrug

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

Sichuan Haisco Pharmaceutical Group Co., Ltd
Industrylead

Study Sites (9)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Chest Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

The Third Hospital of Zhenjiang Affiliated Jiangsu University

Zhenjiang, Jiangsu, China

Renji Hospital

Shanghai, Shanghai Municipality, China

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

polyene phosphatidylcholine18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

Yimin Mao, M.D.
RenJi Hospital
STUDY CHAIR

Enrollment

73 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Polyene Phosphatidylcholine

Magnesium Isoglycyrrhizinate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Polyene Phosphatidylcholine

Magnesium Isoglycyrrhizinate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations