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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by IlDong Pharmaceutical Co Ltd
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier:
NCT02792088
First received: May 31, 2016
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
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

Condition Intervention Phase
Chronic Hepatitis B
Drug: Besifovir 150mg
Drug: Tenofovir 300mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by IlDong Pharmaceutical Co Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of subjects who showed ALT normalized at the 48th week [ Time Frame: at the 48th week ] [ Designated as safety issue: No ]

Estimated Enrollment: 244
Study Start Date: July 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Besifovir
Besifovir 150 mg q.d.
Drug: Besifovir 150mg
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 Name: Besifovir
Active Comparator: Tenofovir
Tenofovir 300 mg q.d.
Drug: Tenofovir 300mg
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 Name: Tenofovir

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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • Was co-infected with hepatitis C of hepatitis D virus or Human Immunodeficiency Virus
  • Had confirmation of adefovir drug resistant mutation
  • At screening, had alpha-fetoprotein (AFP) value > 20 ng/mL and a follow-up ultrasonography performed prior to baseline showed findings indicative of HCC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02792088

Contacts
Contact: Junghee Won, Master 82-2-526-3512 jh-won@ildong.com
Contact: Yoan Park, Master 82-2-526-3524 yapark@ildong.com

Locations
Korea, Republic of
Severance Hospital of Yonsei University Recruiting
Seoul, Korea, Republic of
Contact: Kwang-Hyub Han, M.D., Ph.D.         
Principal Investigator: Kwang-Hyub Han, M.D., Ph.D.         
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
Principal Investigator: Kwang-Hyub Han, M.D, Ph.D. Severance Hospital of Yonsei University
  More Information

Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02792088     History of Changes
Other Study ID Numbers: ID_BVCL012 
Study First Received: May 31, 2016
Last Updated: June 7, 2016
Health Authority: Korea: Ministry of Food and Drug Safety
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by IlDong Pharmaceutical Co Ltd:
HBV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on December 07, 2016