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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02289300
• Other study ID #: BO1202-LF1201
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2020
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: A2 Healthcare Taiwan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Hepatitis B
• HEPATITIS B CHRONIC
• Hepatitis B, Chronic
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Fibrosis

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
A2 Healthcare Taiwan Corporation	GoldenMed BioTechnology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit		96 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival rates at Week-48 and Week-96 visits		Weeks 48, 96
Secondary	Recurrence rate at Week-96 visit		Week 96
Secondary	Time to recurrence of cancer		Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Secondary	Incidence of adverse events (AEs)		Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Secondary	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