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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Injury Group | Experimental | The patients have liver injuries caused by antitumor drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicyclol tablets | Drug | Take Bicyclol tablets for the treatment of liver injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of ALT levels compared with baseline | ALT changes at other time points （1 week, 2 week, 3 week) compared with baseline | less than 4 weeks |
| The changes of AST levels compared with baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Lu, M.D | Contact | +86-22-23340123 | 3089 | mail4luwei@163.com |
| Ningning Zhang, M.D | Contact | +86-18920168107 | mail4ningning@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Lu, M.D | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16481640 | Background | 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. | |
| 28341748 | Background | 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. |
| Label | URL |
|---|---|
| PMID: 28341748 | View source |
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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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| ID | Term |
|---|---|
| D056486 | Chemical and Drug Induced Liver Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C477843 | bicyclol |
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AST changes at other time points （1 week, 2 week, 3 week) compared with baseline
| 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 | 6 months |
| 12143055 | Background | 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. |
| 23419359 | Background | 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. |
| 17156142 | Background | 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. |
| 17697161 | Background | 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. |
| 25754159 | Background | 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. |
| 8229110 | Background | 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. |
| 20512999 | Background | 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. |
| 26517184 | Background | 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. |
| 31314970 | Background | 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. |
| 29607414 | Background | 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. |
| 29200411 | Background | 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. |
| PMID: 23419359 | View source |
| PMID: 25754159 | View source |
| PMID: 8229110 | View source |
| PMID: 29607414 | View source |
| PMID: 29200411 | View source |
| D011041 | Poisoning |