NCT05711459|Unknown
Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
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A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
Sponsor study identifier
interventional
5,405
1 country
1
Study Start
May 1, 2022
Actual (reported)Primary Completion
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2022
Actual (reported)November 13, 2022
Actual (reported)February 3, 2023
Actual (reported)May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
4 weeks
The changes of ALT levels compared with baseline
less than 4 weeks
The changes of AST levels compared with baseline
less than 4 weeks
The condition of acute liver injuries becomes the chronic liver disease
6 months
The patients have liver injuries caused by antitumor drugs.
Take Bicyclol tablets for the treatment of liver injury.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
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.
Kullak-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.
Sgro 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.
Wei Lu, M.D
Tianjin Medical University Cancer Institute and Hospital
First Submitted
November 13, 2022
First Posted
February 3, 2023
Study Start
May 1, 2022
Actual (reported)Primary Completion
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Bjornsson 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.
Vuppalanchi 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.
Wei 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.
Chalasani 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.
Danan 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.
Rockey 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.
Bjornsson 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.
Hoofnagle 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.
Chen 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.
Naiqiong 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.
Study Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 3, 2023
Record last verified: 2022-12
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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Source: ClinicalTrials.gov.
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