Overview

A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients

Status:
Withdrawn
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
A2 Healthcare Taiwan Corporation
Collaborator:
GoldenMed BioTechnology
Criteria
Inclusion Criteria:

1. Aged 20-65 years (inclusive) of either gender

2. With evidence of HBV infection confirmed by positive for Hepatitis B virus antigen
(HBsAg)

3. With Barcelona Clinic Liver Cancer (BCLC) intermediate stage (BCLC-B) hepatocellular
carcinoma (HCC)

4. Having received radiofrequency ablation (RFA) or transarterial embolization (TAE) for
hepatitis B virus (HBV) related hepatocellular carcinoma at least 4 weeks before
Screening

5. With liver stiffness measurement (assessed by Fibroscan®) of 7-20 kPa

6. Able to understand and willing to sign the informed consent

Exclusion Criteria:

1. Evidence or history of chronic hepatitis caused by Hepatitis C virus (HCV)

2. 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

3. With uncontrolled infection or serious infection within the past 4 weeks

4. With any other carcinoma except skin cancer

5. Women who are pregnant or breast-feeding or with child-bearing potential but unable or
unwilling to practice a highly effective means of contraception

6. Active substance abuse, including alcohol, which, in the opinion of the investigator,
risks impairing the ability of the patient to comply with the protocol

7. History of allergy to any substance of investigational products

8. With known human immunodeficiency virus (HIV) infection

9. Judged to be not applicable to this study by investigator such as difficulty of
follow-up observation

10. With any other serious diseases/medical history considered by the investigator not in
the condition to enter the trial

11. 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.)

12. Having participated other investigational study within 4 weeks of entering this study