Drug-Induced Liver InjuryPhase 2NCT02734966
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
A Phase 2 study testing Magnesium Isoglycyrrhizinate Injection 100mg OD, Magnesium Isoglycyrrhizinate Injection 200mg OD and Tiopronin Injection in people with Drug-Induced Liver Injury, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drug-Induced Liver Injury
- What is being tested?
- Magnesium Isoglycyrrhizinate Injection 100mg OD, Magnesium Isoglycyrrhizinate Injection 200mg OD and Tiopronin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 8 sitesChina
- Study dates
- Dec 2007to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality
Integrated Chinese and Western Medicine Hospital of Zhejiang Province
Hangzhou, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Nanjing Pulmonary Hospital
Nanjing, Jiangsu
85 Hospital of People's Liberation Army
Shanghai, Shanghai Municipality
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Multi-center, Randomized, Double-blind, Active Control Phase II Study to Investigate Multiple Dosage and Treatments of Magnesium Isoglycyrrhizinate Injection to Cure the Acute Drug-induced Liver Injury
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.
Read the detailed description
The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.
- Conditions
- Drug-Induced Liver Injury
- Being tested
- Magnesium Isoglycyrrhizinate Injection 100mg OD, Magnesium Isoglycyrrhizinate Injection 200mg OD, Tiopronin Injection
- Keywords
- Drug-Induced, Acute Liver Injury
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Isoglycyrrhizinate Injection 100mg ODDrug
Also called Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Magnesium Isoglycyrrhizinate Injection 100mg OD
Magnesium Isoglycyrrhizinate Injection 200mg ODDrug
Also called Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
Tiopronin InjectionDrug
Also called Jinan Limin Pharmaceutical Co., Ltd.
Tiopronin Injection 200mg OD
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks Receives: Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD |
| arm 2 | Experimental | higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks. Receives: Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD |
| Tiopronin Injection | Active comparator | Tiopronin Injection 200mg OD for 4 weeks Receives: Drug: Tiopronin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ALT normalization at week 4 of treatment
Measured: 4 weeks
Secondary outcomes (3)
rates of ALT normalization at weeks 1, 2, and 3 of treatment
Measured: 3 weeks
change of ALT at weeks 1, 2, 3 and 4 of treatment;
Measured: 4 weeks
change of AST at weeks 1, 2, 3 and 4 of treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug-Induced Liver InjuryStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minde Zeng, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734966
- Sponsor's protocol ID
- ZTDQ01341301
- Status last verified
- Sep 2016
- First submitted
- 6 Apr 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9303497Watkins 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.
PubMed 16496329
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active Control Phase II Study to Investigate Multiple Dosage and Treatments of Magnesium Isoglycyrrhizinate Injection to Cure the Acute Drug-induced Liver Injury
- ClinicalTrials.gov ID
- NCT02734966
- Acronym / sponsor ID
- ZTDQ01341301
- Conditions
- Drug-Induced Liver Injury
- Keywords
- Drug-Induced, Acute Liver Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: Magnesium Isoglycyrrhizinate Injection 100mg ODlower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks |
| arm 2 | Experimental | Drug: Magnesium Isoglycyrrhizinate Injection 200mg ODhigher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks. |
| Tiopronin Injection | Active comparator | Drug: Tiopronin InjectionTiopronin Injection 200mg OD for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Isoglycyrrhizinate Injection 100mg ODAlso: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Magnesium Isoglycyrrhizinate Injection 100mg OD | Drug | arm 1 |
| Magnesium Isoglycyrrhizinate Injection 200mg ODAlso: Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks | Drug | arm 2 |
| Tiopronin InjectionAlso: Jinan Limin Pharmaceutical Co., Ltd.Tiopronin Injection 200mg OD | Drug | Tiopronin Injection |
Primary outcome
Rate of ALT normalization at week 4 of treatment
Time frame: 4 weeks
3 secondary outcomes
rates of ALT normalization at weeks 1, 2, and 3 of treatment
Time frame: 3 weeks
change of ALT at weeks 1, 2, 3 and 4 of treatment;
Time frame: 4 weeks
change of AST at weeks 1, 2, 3 and 4 of treatment.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 9303497Maria 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.
- Background: PubMed 16496329Watkins 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.
- Individual participant dataSharing planned: Undecided
Related trials for Drug-Induced Liver Injury
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
Drug-Induced Acute Liver Injury, Tuberculosis (TB)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingPhase 3
Misocholic Tablets for Non-Viral Elevated Liver Enzymes
Alcohol-Related Liver Disease, Drug-Induced Liver Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minde Zeng, MD principal investigator
RenJi Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Isoglycyrrhizinate Injection 100mg OD, Magnesium Isoglycyrrhizinate Injection 200mg OD and Tiopronin Injection in people with Drug-Induced Liver Injury, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ALT normalization at week 4 of treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.