Drug-Induced Acute Liver InjuryNCT05711459
Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
A study testing Bicyclol tablets in people with Drug-Induced Acute Liver Injury, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The clinical trial is designed to evaluate the efficacy of bicyclol for patients with antineoplastic drug-induced liver injury and investigate factors effecting the therapeutic outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-Induced Acute Liver Injury
- What is being tested?
- Bicyclol tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,405 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The acute liver injury caused by anti-tumor drugs
- The RUCAM assessment scale ≥6
- The liver injury must in the acute phase
- Must be treated with bicyclol tablets
- Must sign informed consent -
Who cannot join
- This acute liver injury caused by non-anti-tumor drugs
- Pregnant women
- Lactating women
- Childbearing age women are plan to conceive
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Wei Lu, M.D, +86-22-23340123 ext. 3089, mail4luwei@163.com
Ningning Zhang, M.D, +86-18920168107, mail4ningning@163.com
About this study
Official title: A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
The clinical trial is designed to evaluate the efficacy of bicyclol for patients with antineoplastic drug-induced liver injury and investigate factors effecting the therapeutic outcome.
Read the detailed description
This study prospectively studied the treatment of acute drug-induced liver injury related to anti-tumor with bicyclol tablets, to provide medical evidence in clinical practice of bicyclol treating acute drug-induced liver injury. The main purpose of this study is to evaluate the clinical efficacy and outcome of bicyclol tablets in the treatment of drug-induced liver injury and analyze the bicyclol tablet's therapeutic effects in different groups including conventional chemotherapy drugs, targeted drugs, and immunosuppressants. The secondary purpose of this study is to analyze the factors influencing the prognosis and outcome of bicyclol tablets in the treatment of acute DILI.
- Conditions
- Drug-Induced Acute Liver Injury
- Being tested
- Bicyclol tablets
- Keywords
- Prospective Study, Multicenter Trials, Bicyclol Tablet, Antineoplastic Drug-induced 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.
Bicyclol tabletsDrug
Take Bicyclol tablets for the treatment of liver injury.
| Study group | Role | What they receive |
|---|---|---|
| Liver Injury Group | Experimental | The patients have liver injuries caused by antitumor drugs. Receives: Drug: Bicyclol tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in ALT level from baseline after 4 weeks treatment of bicyclol
Excellence: clinical symptoms and signs disappeared, serum ALT returned to normal; Improvement: clinical symptoms disappeared (improved), serum ALT decreased more than 50% of the original value; Invalid: Failure to meet the above criteria
Measured: 4 weeks
Secondary outcomes (3)
The changes of ALT levels compared with baseline
ALT changes at other time points （1 week, 2 week, 3 week) compared with baseline
Measured: less than 4 weeks
The changes of AST levels compared with baseline
AST changes at other time points （1 week, 2 week, 3 week) compared with baseline
Measured: less than 4 weeks
The condition of acute liver injuries becomes the chronic liver disease
Proportion of patients with chronic drug-induced liver injury after 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Drug-Induced Acute Liver InjuryStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,405 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Lu, M.D, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711459
- Sponsor's protocol ID
- BDILI
- Status last verified
- Dec 2022
- First submitted
- 13 Nov 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the principle of confidentiality of subjects' privacy and related information, this plan not to make IPD available to other researchers.
Publications
Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006 Feb 16;354(7):731-9. doi: 10.1056/NEJMra052270. No abstract available.
PubMed 16481640Kullak-Ublick GA, Andrade RJ, Merz M, End P, Benesic A, Gerbes AL, Aithal GP. Drug-induced liver injury: recent advances in diagnosis and risk assessment. Gut. 2017 Jun;66(6):1154-1164. doi: 10.1136/gutjnl-2016-313369. Epub 2017 Mar 23.
PubMed 28341748Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, Lenoir C, Lemoine A, Hillon P. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology. 2002 Aug;36(2):451-5. doi: 10.1053/jhep.2002.34857.
PubMed 12143055Bjornsson ES, Bergmann OM, Bjornsson HK, Kvaran RB, Olafsson S. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013 Jun;144(7):1419-25, 1425.e1-3; quiz e19-20. doi: 10.1053/j.gastro.2013.02.006. Epub 2013 Feb 16.
PubMed 23419359Vuppalanchi R, Liangpunsakul S, Chalasani N. Etiology of new-onset jaundice: how often is it caused by idiosyncratic drug-induced liver injury in the United States? Am J Gastroenterol. 2007 Mar;102(3):558-62; quiz 693. doi: 10.1111/j.1572-0241.2006.01019.x.
PubMed 17156142Wei G, Bergquist A, Broome U, Lindgren S, Wallerstedt S, Almer S, Sangfelt P, Danielsson A, Sandberg-Gertzen H, Loof L, Prytz H, Bjornsson E. Acute liver failure in Sweden: etiology and outcome. J Intern Med. 2007 Sep;262(3):393-401. doi: 10.1111/j.1365-2796.2007.01818.x.
PubMed 17697161Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, Watkins PB, Navarro V, Barnhart H, Gu J, Serrano J; United States Drug Induced Liver Injury Network. Features and Outcomes of 899 Patients With Drug-Induced Liver Injury: The DILIN Prospective Study. Gastroenterology. 2015 Jun;148(7):1340-52.e7. doi: 10.1053/j.gastro.2015.03.006. Epub 2015 Mar 6.
PubMed 25754159Danan G, Benichou C. Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol. 1993 Nov;46(11):1323-30. doi: 10.1016/0895-4356(93)90101-6.
PubMed 8229110Rockey DC, Seeff LB, Rochon J, Freston J, Chalasani N, Bonacini M, Fontana RJ, Hayashi PH; US Drug-Induced Liver Injury Network. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method. Hepatology. 2010 Jun;51(6):2117-26. doi: 10.1002/hep.23577.
PubMed 20512999Bjornsson ES, Hoofnagle JH. Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports. Hepatology. 2016 Feb;63(2):590-603. doi: 10.1002/hep.28323. Epub 2015 Dec 21.
PubMed 26517184Hoofnagle JH, Bjornsson ES. Drug-Induced Liver Injury - Types and Phenotypes. N Engl J Med. 2019 Jul 18;381(3):264-273. doi: 10.1056/NEJMra1816149. No abstract available.
PubMed 31314970Chen Y, Ye P, Ren C, Ren P, Ma Z, Zhang L, Zhou W, Jiang C. Pharmacoeconomics of three Therapeutic Schemes for Anti-tuberculosis Therapy Induced Liver Injury in China. Open Med (Wars). 2018 Mar 21;13:53-63. doi: 10.1515/med-2018-0010. eCollection 2018.
PubMed 29607414Naiqiong W, Liansheng W, Zhanying H, Yuanlin G, Chenggang Z, Ying G, Qian D, Dongchen L, Yanjun Z, Jianjun L. A Multicenter and Randomized Controlled Trial of Bicyclol in the Treatment of Statin-Induced Liver Injury. Med Sci Monit. 2017 Dec 4;23:5760-5766. doi: 10.12659/msm.904090.
PubMed 29200411
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
- ClinicalTrials.gov ID
- NCT05711459
- Acronym / sponsor ID
- BDILI
- Conditions
- Drug-Induced Acute Liver Injury
- Keywords
- Prospective Study, Multicenter Trials, Bicyclol Tablet, Antineoplastic Drug-induced Liver Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,405 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Feb 2023 (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 clinical trial is designed to evaluate the efficacy of bicyclol for patients with antineoplastic drug-induced liver injury and investigate factors effecting the therapeutic outcome.
Detailed description
This study prospectively studied the treatment of acute drug-induced liver injury related to anti-tumor with bicyclol tablets, to provide medical evidence in clinical practice of bicyclol treating acute drug-induced liver injury. The main purpose of this study is to evaluate the clinical efficacy and outcome of bicyclol tablets in the treatment of drug-induced liver injury and analyze the bicyclol tablet's therapeutic effects in different groups including conventional chemotherapy drugs, targeted drugs, and immunosuppressants. The secondary purpose of this study is to analyze the factors influencing the prognosis and outcome of bicyclol tablets in the treatment of acute DILI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Injury Group | Experimental | Drug: Bicyclol tabletsThe patients have liver injuries caused by antitumor drugs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The acute liver injury caused by anti-tumor drugs
- The RUCAM assessment scale ≥6
- The liver injury must in the acute phase
- Must be treated with bicyclol tablets
- Must sign informed consent -
Key exclusion criteria (4 listed)
- This acute liver injury caused by non-anti-tumor drugs
- Pregnant women
- Lactating women
- Childbearing age women are plan to conceive
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 tabletsTake Bicyclol tablets for the treatment of liver injury. | Drug | Liver Injury Group |
Primary outcome
The changes in ALT level from baseline after 4 weeks treatment of bicyclol
Time frame: 4 weeks
Excellence: clinical symptoms and signs disappeared, serum ALT returned to normal; Improvement: clinical symptoms disappeared (improved), serum ALT decreased more than 50% of the original value; Invalid: Failure to meet the above criteria
3 secondary outcomes
The changes of ALT levels compared with baseline
Time frame: less than 4 weeks
The changes of AST levels compared with baseline
Time frame: less than 4 weeks
The condition of acute liver injuries becomes the chronic liver disease
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 16481640Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006 Feb 16;354(7):731-9. doi: 10.1056/NEJMra052270. No abstract available.
- Background: PubMed 28341748Kullak-Ublick GA, Andrade RJ, Merz M, End P, Benesic A, Gerbes AL, Aithal GP. Drug-induced liver injury: recent advances in diagnosis and risk assessment. Gut. 2017 Jun;66(6):1154-1164. doi: 10.1136/gutjnl-2016-313369. Epub 2017 Mar 23.
- Background: PubMed 12143055Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, Lenoir C, Lemoine A, Hillon P. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology. 2002 Aug;36(2):451-5. doi: 10.1053/jhep.2002.34857.
- Background: PubMed 23419359Bjornsson ES, Bergmann OM, Bjornsson HK, Kvaran RB, Olafsson S. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013 Jun;144(7):1419-25, 1425.e1-3; quiz e19-20. doi: 10.1053/j.gastro.2013.02.006. Epub 2013 Feb 16.
- Background: PubMed 17156142Vuppalanchi R, Liangpunsakul S, Chalasani N. Etiology of new-onset jaundice: how often is it caused by idiosyncratic drug-induced liver injury in the United States? Am J Gastroenterol. 2007 Mar;102(3):558-62; quiz 693. doi: 10.1111/j.1572-0241.2006.01019.x.
- Background: PubMed 17697161Wei G, Bergquist A, Broome U, Lindgren S, Wallerstedt S, Almer S, Sangfelt P, Danielsson A, Sandberg-Gertzen H, Loof L, Prytz H, Bjornsson E. Acute liver failure in Sweden: etiology and outcome. J Intern Med. 2007 Sep;262(3):393-401. doi: 10.1111/j.1365-2796.2007.01818.x.
- Background: PubMed 25754159Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, Watkins PB, Navarro V, Barnhart H, Gu J, Serrano J; United States Drug Induced Liver Injury Network. Features and Outcomes of 899 Patients With Drug-Induced Liver Injury: The DILIN Prospective Study. Gastroenterology. 2015 Jun;148(7):1340-52.e7. doi: 10.1053/j.gastro.2015.03.006. Epub 2015 Mar 6.
- Background: PubMed 8229110Danan G, Benichou C. Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol. 1993 Nov;46(11):1323-30. doi: 10.1016/0895-4356(93)90101-6.
- Background: PubMed 20512999Rockey DC, Seeff LB, Rochon J, Freston J, Chalasani N, Bonacini M, Fontana RJ, Hayashi PH; US Drug-Induced Liver Injury Network. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method. Hepatology. 2010 Jun;51(6):2117-26. doi: 10.1002/hep.23577.
- Background: PubMed 26517184Bjornsson ES, Hoofnagle JH. Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports. Hepatology. 2016 Feb;63(2):590-603. doi: 10.1002/hep.28323. Epub 2015 Dec 21.
- Background: PubMed 31314970Hoofnagle JH, Bjornsson ES. Drug-Induced Liver Injury - Types and Phenotypes. N Engl J Med. 2019 Jul 18;381(3):264-273. doi: 10.1056/NEJMra1816149. No abstract available.
- Background: PubMed 29607414Chen Y, Ye P, Ren C, Ren P, Ma Z, Zhang L, Zhou W, Jiang C. Pharmacoeconomics of three Therapeutic Schemes for Anti-tuberculosis Therapy Induced Liver Injury in China. Open Med (Wars). 2018 Mar 21;13:53-63. doi: 10.1515/med-2018-0010. eCollection 2018.
- PMID: 16481640Link provided by the sponsor.
- PMID: 28341748Link provided by the sponsor.
- PMID: 23419359Link provided by the sponsor.
- PMID: 25754159Link provided by the sponsor.
- PMID: 8229110Link provided by the sponsor.
- PMID: 29607414Link provided by the sponsor.
- Individual participant dataSharing planned: No. Based on the principle of confidentiality of subjects' privacy and related information, this plan not to make IPD available to other researchers.
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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.
Wei Lu, M.D study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicyclol tablets in people with Drug-Induced Acute Liver Injury, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 5 inclusion and 4 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Wei Lu, M.D (+86-22-23340123 ext. 3089, mail4luwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in ALT level from baseline after 4 weeks treatment of bicyclol (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 NCT05711459, which also lists 13 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 3 Feb 2023.