Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury

NCT02734966 | Completed Phase 2

• 1 other identifier: ZTDQ01341301
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.

Conditions

Drug-Induced Liver Injury

Keywords

Drug-Induced; Acute Liver Injury

Outcome Measures

Primary Outcomes (1)

• Rate of ALT normalization at week 4 of treatment

  4 weeks

Secondary Outcomes (3)

• rates of ALT normalization at weeks 1, 2, and 3 of treatment

  3 weeks

• change of ALT at weeks 1, 2, 3 and 4 of treatment;

  4 weeks

• change of AST at weeks 1, 2, 3 and 4 of treatment.

  4 weeks

Study Arms (3)

arm 1

EXPERIMENTAL

lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks

Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD

arm 2

EXPERIMENTAL

higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.

Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD

Tiopronin Injection

ACTIVE COMPARATOR

Tiopronin Injection 200mg OD for 4 weeks

Drug: Tiopronin Injection

Interventions

Magnesium Isoglycyrrhizinate Injection 100mg OD DRUG

Magnesium Isoglycyrrhizinate Injection 100mg OD

Also known as: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

arm 1

Magnesium Isoglycyrrhizinate Injection 200mg OD DRUG

Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks

Also known as: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

arm 2

Tiopronin Injection DRUG

Tiopronin Injection 200mg OD

Also known as: Jinan Limin Pharmaceutical Co., Ltd.

Tiopronin Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RACUM ≥6
• ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal
• Liver biochemical abnormalities duration of no more than three months
• Patients need to fully understand and sign the inform consent form.

You may not qualify if:

• The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease.
• The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range.
• The value of the TBiL is \> 3ULN.
• The value of serum creatinine is \> 1.5ULN.
• Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract.
• Patients who are taking the drugs that might interfere the trial.
• Patients who are allergic or intolerant to the study drug.
• Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis.
• Patients who are compliant with protocol.
• Women who are pregnant, breast-feeding or with childbearing potential.
• Patients who have attended other clinical trials within 3 months.
• Not appropriate to be included after assessing by the investigators.
• ULN=Upper Limited Normal

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (8)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Nanjing Pulmonary Hospital

Nanjing, Jiangsu, China

Location

85 Hospital of People's Liberation Army

Shanghai, Shanghai Municipality, China

Location

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Integrated Chinese and Western Medicine Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (2)

• Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology. 1997 Sep;26(3):664-9. doi: 10.1002/hep.510260319.

  PMID: 9303497 BACKGROUND

• Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.

  PMID: 16496329 BACKGROUND

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate; Long-Term Synaptic Depression; Tiopronin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; N-substituted Glycines; Glycine

Study Officials

• Minde Zeng, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2011
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CN (8)