Status:
WITHDRAWN
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients
Lead Sponsor:
A2 Healthcare Taiwan Corporation
Collaborating Sponsors:
GoldenMed BioTechnology
Conditions:
Liver Fibrosis
HEPATITIS B CHRONIC
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief 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 hepa...
Detailed Description
The study will include the first 188 subjects who are randomized. The purpose of study is to collect efficacy results to evaluate treatment effect on the primary endpoint. The second endpoints is to e...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- Administered with any anti-HBV drugs within 4 weeks of entering this study. (Note: Anti-HBV treatments are allowed to be taken during study period when necessary.)
- Having participated other investigational study within 4 weeks of entering this study
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02289300
Start Date
January 1 2020
End Date
December 1 2021
Last Update
January 13 2020
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100