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

A2 Healthcare

Status and phase: Withdrawn; Phase 2

Conditions: HEPATITIS B CHRONIC; Hepatocellular Carcinoma; Liver Fibrosis

Treatments: Drug: DCB-BO1202; Drug: Placebo; Drug: DCB-BO1202+Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02289300

BO1202-LF1201

Details and patient eligibility

About

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)

Full 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 evaluate drug safety on the incidence of the primary endpoint through the treatment period.

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

DCB-BO1202

Experimental group

Treatment:

Drug: DCB-BO1202

DCB-BO1202+Placebo

Experimental group

Treatment:

Drug: DCB-BO1202+Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo