Acute Drug Induced Liver InjuryPhase 4NCT04595916
Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
A Phase 4 study testing Polyene phosphatidylcholine injection 930 mg QD and Magnesium Isoglycyrrhizinate injection 200 mg QD in people with Acute Drug Induced Liver Injury, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Drug Induced Liver Injury
- What is being tested?
- Polyene phosphatidylcholine injection 930 mg QD and Magnesium Isoglycyrrhizinate injection 200 mg QD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 9 sitesChina
- Study dates
- 4 Apr 2020to 2 Nov 2020
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Chest Hospital of Capital Medical University
Beijing, Beijing Municipality
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
The Second Hospital of Anhui Medical University
Hefei, Anhui
Renji Hospital
Shanghai, Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Tongji Hospital
Shanghai, Shanghai Municipality
Shenzhen People's Hospital
Shenzhen, Guangdong
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan
The Third Hospital of Zhenjiang Affiliated Jiangsu University
Zhenjiang, Jiangsu
About this study
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
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.
Read the 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.
- Conditions
- Acute Drug Induced Liver Injury
- Being tested
- Polyene phosphatidylcholine injection 930 mg QD, Magnesium Isoglycyrrhizinate injection 200 mg QD
- Keywords
- ADILI
- 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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Polyene Phosphatidylcholine | Experimental | Not described Receives: Drug: Polyene phosphatidylcholine injection 930 mg QD |
| Magnesium Isoglycyrrhizinate | Active comparator | Not described Receives: Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ALT normalization rate
The serum ALT normalization rate of treatment for 2-4 weeks
Measured: After 2-4 weeks treatment
Secondary outcomes (9)
The serum ALT normalization rate for 1, 2 and 3 weeks
Measured: After 1, 2 and 3 weeks treatment
Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks
Measured: 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
Measured: After 1, 2, 3 and 4 weeks treatment
The serum AST normalization rate for 1, 2, 3 and 4 weeks
Measured: After 1, 2, 3 and 4 weeks treatment
Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks
Measured: After 1, 2, 3 and 4 weeks treatment
The serum TBIL normalization rate for 1, 2, 3 and 4 weeks
Measured: After 1, 2, 3 and 4 weeks treatment
Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks
Measured: After 1, 2, 3 and 4 weeks treatment
Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks
Measured: After 1, 2, 3 and 4 weeks treatment
The Incidence of Treatment-Emergent Adverse Events over time
Measured: After 2 to 4 weeks of treatment and 1 week of safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start4 Apr 2020
- Primary completion21 Oct 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Drug Induced Liver InjuryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yimin Mao, M.D., Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595916
- Sponsor's protocol ID
- HSK-28-201
- Status last verified
- Nov 2020
- First submitted
- 14 Oct 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04595916
- Acronym / sponsor ID
- HSK-28-201
- Conditions
- Acute Drug Induced Liver Injury
- Keywords
- ADILI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyene Phosphatidylcholine | Experimental | Drug: Polyene phosphatidylcholine injection 930 mg QD |
| Magnesium Isoglycyrrhizinate | Active comparator | Drug: Magnesium Isoglycyrrhizinate injection 200 mg QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Polyene phosphatidylcholine injection 930 mg QDPolyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks. | Drug | Polyene Phosphatidylcholine |
| Magnesium Isoglycyrrhizinate injection 200 mg QDMagnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks. | Drug | Magnesium Isoglycyrrhizinate |
Primary outcome
Serum ALT normalization rate
Time frame: After 2-4 weeks treatment
The serum ALT normalization rate of treatment for 2-4 weeks
9 secondary outcomes
The serum ALT normalization rate for 1, 2 and 3 weeks
Time frame: After 1, 2 and 3 weeks treatment
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
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
The serum AST normalization rate for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
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
The serum TBIL normalization rate for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
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
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
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
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 24 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Yimin Mao, M.D. study chair
RenJi Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyene phosphatidylcholine injection 930 mg QD and Magnesium Isoglycyrrhizinate injection 200 mg QD in people with Acute Drug Induced Liver Injury, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 9 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Serum ALT normalization rate (time frame: After 2-4 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2020.