A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Pati… (NCT02289300) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients
Stopped: At sponsor's discretion
Taiwan0Started 2020-01
Plain-language summary
The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)
Who can participate
Age range20 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 20-65 years (inclusive) of either gender
✓. With evidence of HBV infection confirmed by positive for Hepatitis B virus antigen (HBsAg)
✓. With Barcelona Clinic Liver Cancer (BCLC) intermediate stage (BCLC-B) hepatocellular carcinoma (HCC)
✓. Having received radiofrequency ablation (RFA) or transarterial embolization (TAE) for hepatitis B virus (HBV) related hepatocellular carcinoma at least 4 weeks before Screening
✓. With liver stiffness measurement (assessed by Fibroscan®) of 7-20 kPa
✓. Able to understand and willing to sign the informed consent
Exclusion criteria
✕. Evidence or history of chronic hepatitis caused by Hepatitis C virus (HCV)
✕. With abnormal organ functions such as absolute neutrophil count (ANC) \< 1500 /μL, hemoglobin \< 9 gm/dL, platelets \< 50,000 /μL, creatinine \> 2 mg/dL, alanine aminotransferase (AST) or ALT \> 5 X upper normal limit of the current institution; bilirubin \> 2.5 mg/dL, prothrombin time (PT) prolongation \> 4 sec above upper limit of normal
✕. With uncontrolled infection or serious infection within the past 4 weeks
✕. With any other carcinoma except skin cancer
✕. Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
What they're measuring
1
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
✕. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
✕. History of allergy to any substance of investigational products
✕. With known human immunodeficiency virus (HIV) infection