NCT05711459

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,405

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 3, 2023

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

November 13, 2022

Last Update Submit

February 2, 2023

Conditions

Drug-Induced Acute Liver Injury

Keywords

Prospective StudyMulticenter TrialsBicyclol TabletAntineoplastic Drug-induced Liver Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (1)

Liver Injury Group

EXPERIMENTAL

The patients have liver injuries caused by antitumor drugs.

Drug: Bicyclol tablets

Interventions

Bicyclol tabletsDRUG

Take Bicyclol tablets for the treatment of liver injury.

Liver Injury Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • This acute liver injury caused by non-anti-tumor drugs
  • Pregnant women
  • Lactating women
  • Childbearing age women are plan to conceive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (13)

  • 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.

    PMID: 16481640BACKGROUND

  • 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.

    PMID: 28341748BACKGROUND

  • 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.

    PMID: 12143055BACKGROUND

  • 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.

    PMID: 23419359BACKGROUND

  • 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.

    PMID: 17156142BACKGROUND

  • 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.

    PMID: 17697161BACKGROUND

  • 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.

    PMID: 25754159BACKGROUND

  • 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.

    PMID: 8229110BACKGROUND

  • 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.

    PMID: 20512999BACKGROUND

  • 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.

    PMID: 26517184BACKGROUND

  • 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.

    PMID: 31314970BACKGROUND

  • 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.

    PMID: 29607414BACKGROUND

  • 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: 29200411BACKGROUND

Related Links

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

bicyclol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

  • Wei Lu, M.D

    Tianjin Medical University Cancer Institute and Hospital

    STUDY CHAIR

Central Study Contacts

Wei Lu, M.D

CONTACT

+86-22-23340123mail4luwei@163.com

Ningning Zhang, M.D

CONTACT

+86-18920168107mail4ningning@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2022

First Posted

February 3, 2023

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

February 3, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Based on the principle of confidentiality of subjects' privacy and related information, this plan not to make IPD available to other researchers.

Locations

CN(1)