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

NCT02289300 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-13

No results posted yet for this study

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)

Conditions

Interventions

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)

DRUG

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)

DRUG

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)

Sponsors & Collaborators

  • GoldenMed BioTechnology

    collaborator UNKNOWN

  • A2 Healthcare Taiwan Corporation

    lead INDUSTRY

Principal Investigators

  • Kai-Wen Huang, MD · Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02289300 on ClinicalTrials.gov