NCT02289300

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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
5.1 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

November 7, 2014

Last Update Submit

January 10, 2020

Conditions

Liver FibrosisHEPATITIS B CHRONICHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

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

    96 weeks

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (3)

DCB-BO1202

EXPERIMENTAL
Drug: DCB-BO1202

DCB-BO1202+Placebo

EXPERIMENTAL
Drug: DCB-BO1202+Placebo

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DCB-BO1202DRUG

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
PlaceboDRUG

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)

Placebo
DCB-BO1202+PlaceboDRUG

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)

DCB-BO1202+Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Liver CirrhosisHepatitis B, ChronicCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisChronic DiseaseDisease AttributesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Kai-Wen Huang, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 13, 2014

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

December 1, 2021

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

TW(1)