Clinical trial · Interventional
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
NCT02289300CI-TRIAL-00042738withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): At sponsor's discretion
Summary
Brief summary (as posted)
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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HEPATITIS B CHRONIC | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCB-BO1202 | Drug | — | UNRESOLVED |
| DCB-BO1202+Placebo | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DCB-BO1202
- interventionNames
- Drug: DCB-BO1202
- type
- EXPERIMENTAL
- label
- DCB-BO1202+Placebo
- interventionNames
- Drug: DCB-BO1202+Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.