Drug-Induced Acute Liver InjuryPhase 2NCT02944552

The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI

A Phase 2 study testing bicyclol tablet 25mg, bicyclol tablet 50mg and polyene phosphatidylcholine capsule 456mg in people with Drug-Induced Acute Liver Injury, run by Drug Induced Liver Disease Study Group at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study adopted the superiority design of multi center, randomized, double-blind, positive control drug, dose finding, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group, high dose 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 tablet 25mg, bicyclol tablet 50mg and polyene phosphatidylcholine capsule 456mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 244 participants
Where: 17 sitesChina
Study dates: 18 Aug 2017to 31 Jul 2019
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-75 years old, male or female;
Meet 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, at least two of three liver disease experts should have the same judgment;
The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN;
Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less 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

Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc;
Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, ascites, albumin is less than or equal to 35g / L, The international standardized ratio (INR) of thrombin is more than 1.5;
Serum creatinine is more than 1.5 times ULN;
Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
Taking drugs that may affect observation of curative effect of the experimental drug during the study;
Allergy or intolerance to experimental drugs;

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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 three days;
The researchers believe not suitable.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

China17 sites

Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350025
Anhui Provincial Hospital
Hefei, Anhui
Jiangsu Province Hospital
Nanjing, Jiangsu
Renji Hospital ，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
No.85 hospital of PLA
Shanghai, Shanghai Municipality
Ruijin Hospital ，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality
Shanghai Lung Hospital
Shanghai
Tianjin Haihe Hospital
Tianjin, Tianjin Municipality
The First affiliated Hospital of Xinxiang Medical University
Weihui, Henan
Henan Infectious Diseases Hospital
Zhengzhou, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan

Other trials in China

About this study

Official title: The Multi Center, Randomized, Double-blind, Positive Controlled Phase II Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury

Read the detailed description

Explore the safety and efficacy of different doses of bicyclol in 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, dose finding, positive control drug, superiority test, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group and high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.

Conditions: Drug-Induced Acute Liver Injury
Being tested: bicyclol tablet 25mg, bicyclol tablet 50mg, polyene phosphatidylcholine capsule 456mg
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 tablet 25mgDrug
Also called bicyclol blank analog tablet, polyene phosphatidylcholine blank analog capsule
Patients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
bicyclol tablet 50mgDrug
Also called polyene phosphatidylcholine blank analog capsule
Patients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
polyene phosphatidylcholine capsule 456mgDrug
Also called bicyclol blank analog tablet
Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.

Study groups in NCT02944552
Study group	Role	What they receive
low dose group	Experimental	Patients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks. Receives: Drug: bicyclol tablet 25mg
high dose group	Experimental	Patients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks. Receives: Drug: bicyclol tablet 50mg
positive drug control group	Active comparator	Patients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks. Receives: Drug: polyene phosphatidylcholine capsule 456mg

What is being measured

The primary outcome is the main question the study is designed to answer.

The decline range of serum ALT after 4 weeks of treatment
The decrease value of serum ALT after 4 weeks of treatment compared to the baseline
Measured: after 4 weeks of treatment

Secondary outcomes (7)

The decrease value of serum AST compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The decrease value of serum AST compared to the baseline
Measured: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease value of serum ALT compared to the baseline of treatment for 1, 2, 6, 8 weeks and follow-up for 2, 4 weeks
The decrease value of serum ALT compared to the baseline
Measured: after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease rate of serum ALT compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The decrease rate of serum ALT compared to the baseline
Measured: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The time from treatment to ALT normalization
The time from treatment to ALT normalization
Measured: treatment period
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line
Measured: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The serum ALT and AST normalization rate
Measured: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The area under curve of ALT and AST
Measured: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 201731 Jul 2019

First posted26 Oct 2016 (estimated)
Study start18 Aug 2017
Primary completion10 Jun 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02944552
Sponsor's protocol ID: YL-SHC-2015
Status last verified: Apr 2020
First submitted: 24 Oct 2016
Last updated: 28 Apr 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tang J, Gu J, Chu N, Chen Y, Wang Y, Xue D, Xie Q, Li L, Mei Z, Wang X, Li J, Chen J, Li Y, Yang C, Wang Y, Shang J, Xie W, Hu P, Li D, Zhao L, Lan P, Wang C, Chen C, Mao Y. Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial. Liver Int. 2022 Aug;42(8):1803-1813. doi: 10.1111/liv.15290. Epub 2022 May 25.
PubMed 35567757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Drug-Induced Acute Liver Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Multi Center, Randomized, Double-blind, Positive Controlled Phase II Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
ClinicalTrials.gov ID: NCT02944552
Acronym / sponsor ID: YL-SHC-2015
Conditions: Drug-Induced Acute Liver Injury
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: Drug Induced Liver Disease Study GroupUniversity, hospital or other
Collaborators: Beijing Union Pharmaceutical Factory Ltd
Study start: 18 Aug 2017 (actual)
Primary completion: 10 Jun 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 26 Oct 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.

Detailed description

Explore the safety and efficacy of different doses of bicyclol in treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
low dose group	Experimental	Drug: bicyclol tablet 25mgPatients in the low dose group administrated bicyclol tablet 25mg orally, three times daily for 4-8 weeks.
high dose group	Experimental	Drug: bicyclol tablet 50mgPatients in the high dose group administrated bicyclol tablet 50mg orally, three times daily for 4-8 weeks.
positive drug control group	Active comparator	Drug: polyene phosphatidylcholine capsule 456mgPatients in the positive drug control group administrated polyene phosphatidylcholine capsule 456mg orally, three times daily for 4-8 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18-75 years old, male or female;
Meet 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, at least two of three liver disease experts should have the same judgment;
The serum ALT is between 3and 20 times ULN, but TBiL is less than or equal to 2 times ULN;
Liver biochemical indexes(ALT,AST,ALP,GGT,TBiL,albumin,prothrombin time) abnormalities lasted less 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.

Key exclusion criteria (12 listed)

Occurrent liver injury caused by other reasons, such as viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease etc;
Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, ascites, albumin is less than or equal to 35g / L, The international standardized ratio (INR) of thrombin is more than 1.5;
Serum creatinine is more than 1.5 times ULN;
Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases;
Taking drugs that may affect observation of curative effect of the experimental drug during the study;

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 tablet 25mgAlso: bicyclol blank analog tablet, polyene phosphatidylcholine blank analog capsulePatients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.	Drug	low dose group
bicyclol tablet 50mgAlso: polyene phosphatidylcholine blank analog capsulePatients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.	Drug	high dose group
polyene phosphatidylcholine capsule 456mgAlso: bicyclol blank analog tabletPatients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.	Drug	positive drug control group

Primary outcome

The decline range of serum ALT after 4 weeks of treatment
Time frame: after 4 weeks of treatment
The decrease value of serum ALT after 4 weeks of treatment compared to the baseline

7 secondary outcomes

The decrease value of serum AST compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease value of serum ALT compared to the baseline of treatment for 1, 2, 6, 8 weeks and follow-up for 2, 4 weeks
Time frame: after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease rate of serum ALT compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The time from treatment to ALT normalization
Time frame: treatment period
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 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 28 Apr 2020.
Derived from this study: PubMed 35567757Tang J, Gu J, Chu N, Chen Y, Wang Y, Xue D, Xie Q, Li L, Mei Z, Wang X, Li J, Chen J, Li Y, Yang C, Wang Y, Shang J, Xie W, Hu P, Li D, Zhao L, Lan P, Wang C, Chen C, Mao Y. Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial. Liver Int. 2022 Aug;42(8):1803-1813. doi: 10.1111/liv.15290. Epub 2022 May 25.

Related trials for Drug-Induced Acute Liver Injury

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
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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

No.85 hospital of PLA

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 12 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

The decline range 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?

On the ClinicalTrials.gov record for NCT02944552, which also lists 1 linked publication.

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 28 Apr 2020.