NCT02792088

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 21, 2023

Status Verified

August 1, 2022

Enrollment Period

4.6 years

First QC Date

May 31, 2016

Last Update Submit

February 20, 2023

Conditions

Chronic Hepatitis B

Keywords

HBV

Outcome Measures

Primary Outcomes (1)

  • The rate of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week

    at the 48th week

Secondary Outcomes (1)

  • The rate of subjects who showed ALT normalized at the 48th week

    at the 48th week

Study Arms (2)

Besifovir

EXPERIMENTAL

Besifovir 150 mg q.d.

Drug: Besifovir 150mg

Tenofovir

ACTIVE COMPARATOR

Tenofovir 300 mg q.d.

Drug: Tenofovir 300mg

Interventions

Besifovir 150mgDRUG

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.

Also known as: Besifovir
Besifovir
Tenofovir 300mgDRUG

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.

Also known as: Tenofovir
Tenofovir

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital of Yonsei University

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

((1-((2-amino-9H-purin-9-yl)methyl)cyclopropyl)oxy)methylphosphonic acid dipivoxylTenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kwang-Hyub Han, M.D, Ph.D.

    Severance Hospital of Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 7, 2016

Study Start

July 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 21, 2023

Record last verified: 2022-08

Locations

KR(1)