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

A Phase II Randomized, Double-Blind, Placebo Controlled, Parallel Study of DCB-BO1202 for Alleviating Liver Fibrosis in HBV Patients With Intermediate Hepatocellular Carcinoma Receiving Loco-regional Therapies

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)

Study Overview

• Status: Withdrawn
• Conditions: Hepatocellular Carcinoma; Liver Fibrosis; HEPATITIS B CHRONIC
• Intervention / Treatment: Drug: DCB-BO1202; Drug: DCB-BO1202+Placebo; Drug: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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)
EXPERIMENTAL: DCB-BO1202	Drug: 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)
EXPERIMENTAL: DCB-BO1202+Placebo	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit	96 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84
Changes from baseline in biomarkers associated with liver fibrosis at each post-treatment visit compared to baseline	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Changes from baseline in hepatic functions such as liver enzymes, albumin, direct bilirubin and international normalize ratio (INR) at each post-treatment visit compared to baseline	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Change from baseline in log10 HBV deoxyribonucleic acid (DNA) measured by Polymerase chain reaction (PCR) assay at each post-treatment visit and each of post-study follow-up visits compared to baseline	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Transition of HBV DNA detectable status (e.g. <500 copies/mL) by PCR at each post-treatment visit from baseline	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue total score and sub-scores compared to baseline at each post-treatment visit	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Overall survival rates at Week-48 and Week-96 visits	Weeks 48, 96
Recurrence rate at Week-96 visit	Week 96
Time to recurrence of cancer	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Incidence of adverse events (AEs)	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96

Collaborators and Investigators

• Sponsor: A2 Healthcare Taiwan Corporation
• Collaborators: GoldenMed BioTechnology
• Investigators: Principal Investigator: Kai-Wen Huang, MD, Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (ESTIMATE): November 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Liver Neoplasms; Hepatitis, Chronic; Hepatitis; Fibrosis; Carcinoma; Hepatitis B; Carcinoma, Hepatocellular; Hepatitis B, Chronic; Liver Cirrhosis
• Other Study ID Numbers: BO1202-LF1201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No