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

NCT ID: NCT02289300

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2021-12-31

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 hepatocellular carcinoma (HCC)

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

Conditions

Liver Fibrosis; HEPATITIS B CHRONIC; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DCB-BO1202

Group Type: EXPERIMENTAL

DCB-BO1202

Intervention Type: DRUG

The assignment will be as follows:

(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)

DCB-BO1202: 4 DCB-BO1202 300mg capsules, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)

DCB-BO1202+Placebo

Group Type: EXPERIMENTAL

DCB-BO1202+Placebo

Intervention Type: DRUG

The assignment will be as follows:

(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)

DCB-BO1202+Placebo: 2 DCB-BO1202 300mg capsules plus 2 matched placebo, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The assignment will be as follows:

Placebo: 4 matched placebo, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)

Interventions

DCB-BO1202

The assignment will be as follows:

(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)

DCB-BO1202: 4 DCB-BO1202 300mg capsules, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)

Intervention Type: DRUG

Placebo

The assignment will be as follows:

Placebo: 4 matched placebo, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)

Intervention Type: DRUG

DCB-BO1202+Placebo

The assignment will be as follows:

(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)

DCB-BO1202+Placebo: 2 DCB-BO1202 300mg capsules plus 2 matched placebo, t.i.d., orally.

Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GoldenMed BioTechnology

UNKNOWN

Sponsor Role: collaborator

A2 Healthcare Taiwan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai-Wen Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

BO1202-LF1201

Identifier Type: -

Identifier Source: org_study_id