Drug-Induced Acute Liver InjuryPhase 3NCT05063500
The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI
A Phase 3 study testing bicyclol, 25mg/ tablet and polyene phosphatidylcholine capsules, 228mg/ particle. in people with Drug-Induced Acute Liver Injury, run by Drug Induced Liver Disease Study Group at 2 sites in China.
Trial summary
The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug-Induced Acute Liver Injury
- What is being tested?
- bicyclol, 25mg/ tablet and polyene phosphatidylcholine capsules, 228mg/ particle.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 20 Dec 2021to Jun 2023
- Phase
- Phase 3
- 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
- 18~75 years old, male or female;
- When screening, the threshold of serum liver biochemical test meets one of the following criteria: i: ALT≥5ULN; ii: ALP≥2ULN; iii: ALT≥3ULN, and TBiL≥2ULN;
- During the screening, the patients with hepatocellular injury type or mixed type DILI mainly manifested by a significant increase in ALT were mainly selected;
- Meeting the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3~5, the subject needs three liver disease experts to confirm whether he is DILI patient, meanwhile, at least two of three liver disease experts should have the same judgment.
- Liver biochemical indexes (ALT, AST, ALP, GGT, TBiL, albumin, prothrombin time) abnormalities lasted no more than 90 days;
- Patients can understand the nature of the experiment, the nature of the disease, the characteristic of drugs, related treatment methods, and the risk they may need to bear if they participate in the test and sign the informed consent.
Who cannot join
- Liver injury is caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease, etc.;
- Patients with acute or subacute liver failure; patients with acute liver failure or liver decompensation, such as hepatic encephalopathy, ascites, albumin is less than normal value, International normalized ratio (INR) of prothrombin time greater than 1.5;
- Cholestatic DILI;
- Serum creatinine is more than 1.5 times ULN;
- Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
- Simultaneous application of drugs that affect the efficacy of this trial;
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- Allergy or intolerance to experimental drugs;
- With no ability to express their complaints, such as mental illness and severe neurosis patient;
- The patient can not cooperate and poor compliance;
- Pregnant and lactating women or women preparing for pregnancy;
- The patient participated in other clinical trials in 3 months before entering this study;
- Using other liver-protective drugs except ursodeoxycholic acid or ademetionine within last 3 days;
- The researchers consider not suitable.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Renji Hospital ，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Yimin Mao, 13003175438, maoym11968@163.com
- Not yet recruiting
905th Hospital of Pla Navy
Shanghai, Shanghai Municipality
Chengwei Chen, 13901989118, ccw2@163.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Positive-controlled Phase Ⅲ Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
Read the detailed description
Further evaluated the safety and efficacy of bicyclol in the treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.
The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
- Conditions
- Drug-Induced Acute Liver Injury
- Being tested
- bicyclol, 25mg/ tablet, polyene phosphatidylcholine capsules, 228mg/ particle.
- 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.
bicyclol, 25mg/ tabletDrug
Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
polyene phosphatidylcholine capsules, 228mg/ particle.Drug
Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks. Receives: Drug: bicyclol, 25mg/ tablet |
| Control group | Active comparator | Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks. Receives: Drug: polyene phosphatidylcholine capsules, 228mg/ particle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The normalization rate of serum ALT after 4 weeks of treatment
The normalization rate of serum ALT after 4 weeks of treatment
Measured: After 4 weeks of treatment
Secondary outcomes (8)
The normalization rate of serum ALT after 2 weeks of treatment
The normalization rate of serum ALT after 2 weeks of treatment
Measured: After 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
Measured: After 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
Measured: After 4 weeks of treatment
The time from the start of treatment to the return of ALT
The time from the start of treatment to the return of ALT
Measured: Up to 4 weeks
The normalization rate of serum AST after 2 weeks of treatment
The normalization rate of serum AST after 2 weeks of treatment
Measured: After 2 weeks of treatment
The normalization rate of serum AST after 4 weeks of treatment
The normalization rate of serum AST after 4 weeks of treatment
Measured: After 4 weeks of treatment
The decrease in serum AST relative to baseline at 2 weeks of treatment.
The decrease in serum AST relative to baseline at 2 weeks of treatment.
Measured: After 2 weeks of treatment
The decrease in serum AST relative to baseline at 4 weeks of treatment.
The decrease in serum AST relative to baseline at 4 weeks of treatment.
Measured: After 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start20 Dec 2021
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Induced Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drug Induced Liver Disease Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Union Pharmaceutical Factory Ltd
- Responsible party
- Sponsor
- Investigators
- Yimin Mao, Study chair, RenJi HospitalChengwei Chen, Study chair, 905th Hospital of Pla Navy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063500
- Sponsor's protocol ID
- SHC-2020
- Status last verified
- Aug 2022
- First submitted
- 9 Sep 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Positive-controlled Phase Ⅲ Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
- ClinicalTrials.gov ID
- NCT05063500
- Acronym / sponsor ID
- SHC-2020
- Conditions
- Drug-Induced Acute Liver Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Drug Induced Liver Disease Study GroupUniversity, hospital or other
- Collaborators
- Beijing Union Pharmaceutical Factory Ltd
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Oct 2021 (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 study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
Detailed description
Further evaluated the safety and efficacy of bicyclol in the treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.
The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: bicyclol, 25mg/ tabletExperimental group: each oral bicyclol 50mg, three times daily for 4 weeks. |
| Control group | Active comparator | Drug: polyene phosphatidylcholine capsules, 228mg/ particle.Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18~75 years old, male or female;
- When screening, the threshold of serum liver biochemical test meets one of the following criteria: i: ALT≥5ULN; ii: ALP≥2ULN; iii: ALT≥3ULN, and TBiL≥2ULN;
- During the screening, the patients with hepatocellular injury type or mixed type DILI mainly manifested by a significant increase in ALT were mainly selected;
- Meeting the standard of clinical diagnosis of acute drug-induced liver injury, the RUCAM causality scale score is more than or equal to 6 points. If the RUCAM causality scale score is 3~5, the subject needs three liver disease experts to confirm whether he is DILI patient, meanwhile, at least two of three liver disease experts should have the same judgment.
- Liver biochemical indexes (ALT, AST, ALP, GGT, TBiL, albumin, prothrombin time) abnormalities lasted no more than 90 days;
Key exclusion criteria (13 listed)
- Liver injury is caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease, etc.;
- Patients with acute or subacute liver failure; patients with acute liver failure or liver decompensation, such as hepatic encephalopathy, ascites, albumin is less than normal value, International normalized ratio (INR) of prothrombin time greater than 1.5;
- Cholestatic DILI;
- Serum creatinine is more than 1.5 times ULN;
- Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
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 |
|---|---|---|
| bicyclol, 25mg/ tabletExperimental group: each oral bicyclol 50mg, three times daily for 4 weeks. | Drug | Experimental group |
| polyene phosphatidylcholine capsules, 228mg/ particle.Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks. | Drug | Control group |
Primary outcome
The normalization rate of serum ALT after 4 weeks of treatment
Time frame: After 4 weeks of treatment
The normalization rate of serum ALT after 4 weeks of treatment
8 secondary outcomes
The normalization rate of serum ALT after 2 weeks of treatment
Time frame: After 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 2 weeks of treatment;
Time frame: After 2 weeks of treatment
The decrease value in serum ALT relative to baseline at 4 weeks of treatment;
Time frame: After 4 weeks of treatment
The time from the start of treatment to the return of ALT
Time frame: Up to 4 weeks
The normalization rate of serum AST after 2 weeks of treatment
Time frame: After 2 weeks of treatment
The normalization rate of serum AST after 4 weeks of treatment
Time frame: After 4 weeks of treatment
The decrease in serum AST relative to baseline at 2 weeks of treatment.
Time frame: After 2 weeks of treatment
The decrease in serum AST relative to baseline at 4 weeks of treatment.
Time frame: After 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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 study chair
RenJi Hospital
Chengwei Chen study chair
905th Hospital of Pla Navy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bicyclol, 25mg/ tablet and polyene phosphatidylcholine capsules, 228mg/ particle. in people with Drug-Induced Acute Liver Injury, run by Drug Induced Liver Disease Study Group at 2 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 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimin Mao (13003175438, maoym11968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The normalization rate of serum ALT after 4 weeks of treatment (time frame: After 4 weeks of 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 4 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.