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

Primary Purpose

Liver Fibrosis, HEPATITIS B CHRONIC, Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DCB-BO1202
Placebo
DCB-BO1202+Placebo
Sponsored by
A2 Healthcare Taiwan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fibrosis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DCB-BO1202

DCB-BO1202+Placebo

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit

Secondary Outcome Measures

Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit
Changes from baseline in biomarkers associated with liver fibrosis at each post-treatment visit compared to baseline
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
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
Transition of HBV DNA detectable status (e.g. <500 copies/mL) by PCR at each post-treatment visit from baseline
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue total score and sub-scores compared to baseline at each post-treatment visit
Overall survival rates at Week-48 and Week-96 visits
Recurrence rate at Week-96 visit
Time to recurrence of cancer
Incidence of adverse events (AEs)
Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results

Full Information

First Posted
November 7, 2014
Last Updated
January 10, 2020
Sponsor
A2 Healthcare Taiwan Corporation
Collaborators
GoldenMed BioTechnology
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1. Study Identification

Unique Protocol Identification Number
NCT02289300
Brief Title
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
At sponsor's discretion
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A2 Healthcare Taiwan Corporation
Collaborators
GoldenMed BioTechnology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, HEPATITIS B CHRONIC, Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCB-BO1202
Arm Type
Experimental
Arm Title
DCB-BO1202+Placebo
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DCB-BO1202
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
DCB-BO1202+Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84
Title
Changes from baseline in biomarkers associated with liver fibrosis at each post-treatment visit compared to baseline
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
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
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
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
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
Transition of HBV DNA detectable status (e.g. <500 copies/mL) by PCR at each post-treatment visit from baseline
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue total score and sub-scores compared to baseline at each post-treatment visit
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
Overall survival rates at Week-48 and Week-96 visits
Time Frame
Weeks 48, 96
Title
Recurrence rate at Week-96 visit
Time Frame
Week 96
Title
Time to recurrence of cancer
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
Incidence of adverse events (AEs)
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Title
Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results
Time Frame
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Wen Huang, MD
Organizational Affiliation
Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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