- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02792088
Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues (HBV)
February 20, 2023 updated by: IlDong Pharmaceutical Co Ltd
A Phase III, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues
To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Screening Period Subject registration is conducted with confirming selection and exclusion criteria after a written consent form is obtained within 42 days before clinical trial drug administration.
- Baseline Subjects who visit on the date of starting clinical trial drug administration are randomized to a test group or a control group at a ratio of 1:1. Double blindness is applied for both groups.
- Treatment period Subjects are orally administered with a clinical trial drug q.ds.i.d. for 48 weeks and visit at the 0, 4th, 12th, 24th, 36th, and 48th week for an HBV DNA test, laboratory tests, a physical test, vital signs, and adverse events.
- Follow-up period Subjects are provided with appropriate treatment after completing the 48-week trial or dropping out. Subjects visit once at the 60th week for follow-up of adverse events, such as acute deterioration of hepatitis B, and HBV DNA test results. If any treatment is not conducted after 48-week administration, subjects visit at intervals of four weeks until a follow-up visit (60th week) and the same tests with the 24th week visit (Visit 5) are conducted. However, subjects who participate in a 48-week separate extended trial conducted after 48-week administration in this clinical trial do not have a follow-up period.
Study Type
Interventional
Enrollment (Actual)
146
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Severance Hospital of Yonsei University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
- Patients who showed positive HBsAg during screening
- Have developed nucleoside analogue resistant HB
- Had no received nucleotide analogue
Exclusion Criteria:
- Treatment with pegylated interferons within 6 months
- Prior exposure to BSV
- Mutations conferring resistance to ADV
- Serum HBV DNA levels < 69 IU/mL
- Coinfection with hepatitis C, hepatitis D or human immunodeficiency viruses
- ALT levels ≥ 10 x ULN
- Evidence of decompensated liver disease (Total bilirubin > 2 x ULN, prothrombin time > 6 sec prolonged or INR >1.5, serum albumin <2.8 g/dL, uncontrolled ascites, overt hepatic encephalopathy, or Child-Pugh score ≥8)
- Certain laboratory abnormalities (Hemoglobin < 9.0 g/dL, absolute neutrophil count (ANC) < 1 x 109/L (1000/mm3), platelet count < 75 x 109/L (75 x 103/mm3), serum Creatinine > 1.5 mg/dL, or serum amylase > 2 x ULN and Lipase > 2 x ULN)
- Decreased estimated glomerular filtration rates < 50 mL/min
- Presence of hepatocellular carcinoma or elevated alpha feto-protein > 50 ng/mL
- Current use of aspirin or nonsteroidal anti-inflammatory drugs within 2 month
- Current use of immunosuppressive agents within 6 months
- Current use of high dose corticosteroids (prednisolone > 20 mg/day or equivalent dose over 14 days) with 3 months
- History of malignancy within 5 years
- Subjects who are participating in other clinical trials
- Pregnant or lactating women
- Hypersensitivity to the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Besifovir
Besifovir 150 mg q.d.
|
Besifovir 150 mg q.d.
+ Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d.
+ L-carnitine (L-Carn Tab.
330 mg) 660 mg q.d.
Other Names:
|
Active Comparator: Tenofovir
Tenofovir 300 mg q.d.
|
Placebo of Besifovir 150 mg q.d.
+ Tenofovir Disoproxil Fumarate 300 mg q.d.
+ Placebo of L-carnitine (L-Carn Tab.
330 mg) 660 mg q.d.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week
Time Frame: at the 48th week
|
at the 48th week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of subjects who showed ALT normalized at the 48th week
Time Frame: at the 48th week
|
at the 48th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kwang-Hyub Han, M.D, Ph.D., Severance Hospital of Yonsei University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
May 31, 2016
First Submitted That Met QC Criteria
June 6, 2016
First Posted (Estimate)
June 7, 2016
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- ID_BVCL012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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