Liver FibrosisPhase 2NCT02289300
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients
A Phase 2 study testing DCB-BO1202 in people with Liver Fibrosis and HEPATITIS B CHRONIC, run by A2 Healthcare Taiwan Corporation at 1 site in Taiwan.
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) Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Liver Fibrosis, HEPATITIS B CHRONIC, Hepatocellular Carcinoma
- What is being tested?
- DCB-BO1202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2020to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Being tested
- DCB-BO1202, Placebo, DCB-BO1202+Placebo
- Medical subject headings
- Liver Cirrhosis, Hepatitis B, Chronic, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| DCB-BO1202 | Experimental | Not described Receives: Drug: DCB-BO1202 |
| DCB-BO1202+Placebo | Experimental | Not described Receives: Drug: DCB-BO1202+Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
Measured: 96 weeks
Secondary outcomes (11)
Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Overall survival rates at Week-48 and Week-96 visits
Measured: Weeks 48, 96
Recurrence rate at Week-96 visit
Measured: Week 96
Time to recurrence of cancer
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Incidence of adverse events (AEs)
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results
Measured: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: At sponsor's discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- A2 Healthcare Taiwan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GoldenMed BioTechnology
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, MD, Principal investigator, Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289300
- Sponsor's protocol ID
- BO1202-LF1201
- Status last verified
- Jan 2020
- First submitted
- 7 Nov 2014
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02289300
- Acronym / sponsor ID
- BO1202-LF1201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: At sponsor's discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- A2 Healthcare Taiwan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- GoldenMed BioTechnology
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DCB-BO1202 | Experimental | Drug: DCB-BO1202 |
| DCB-BO1202+Placebo | Experimental | Drug: DCB-BO1202+Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCB-BO1202The 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 | DCB-BO1202 |
| PlaceboThe 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 | Placebo |
| DCB-BO1202+PlaceboThe 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) | Drug | DCB-BO1202+Placebo |
Primary outcome
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
Time frame: 96 weeks
11 secondary outcomes
Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Overall survival rates at Week-48 and Week-96 visits
Time frame: Weeks 48, 96
Recurrence rate at Week-96 visit
Time frame: Week 96
Time to recurrence of cancer
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Incidence of adverse events (AEs)
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Related trials for Liver Fibrosis
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
Lipid Profile, Blood Glucose
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruitingPhase 2/3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Primary Biliary Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Wen Huang, MD principal investigator
Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCB-BO1202 in people with Liver Fibrosis and HEPATITIS B CHRONIC, run by A2 Healthcare Taiwan Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.