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

Phase 2

Withdrawn

• Conditions: Liver Fibrosis; HEPATITIS B CHRONIC; Hepatocellular Carcinoma
• Interventions: Drug: DCB-BO1202; Drug: DCB-BO1202+Placebo; Drug: Placebo

• Registration Number: NCT02289300
• Lead Sponsor: A2 Healthcare Taiwan Corporation

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.

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-13
• Status Verified: 2020-01
• Study Start: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13
• Primary Completion: 2021-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCB-BO1202	DCB-BO1202	-
DCB-BO1202+Placebo	DCB-BO1202+Placebo	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan