Study Stopped
Delayed recruitment, unable to meet calculated sample size
Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα
A Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFα Treatment
1 other identifier
interventional
43
1 country
22
Brief Summary
Analysis of effect of anti-TNFα treatment on HBV reactivation among patients with systemic rheumatic disease, especially rheumatoid arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2012
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 24, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedMarch 6, 2017
March 1, 2017
3 years
September 24, 2012
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency (events) of HBV reactivation
1. Elevated HBV DNA titer: ≥1 log10 rise in HBV DNA level compared with baseline level (virologic breakthrough), along with 2. Increase of AST or ALT above 32 x upper limit of normal (ULN) (biochemical breakthrough)
48 weeks
Secondary Outcomes (1)
Incidence of HBV reactivation among different anti-TNFα treatment groups
72 weeks
Study Arms (2)
Experimental Group
EXPERIMENTALEntecavir (Baraclude (Bristol-Myers Squibb) 0.5mg.) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
Control Group
PLACEBO COMPARATORPlacebo of Entecavir (prepared by Bristol-Myers Squibb) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
Interventions
Entecavir (Baraclude (Bristol-Myers Squibb) 0.5mg.) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
Placebo of Entecavir (prepared by Bristol-Myers Squibb) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
Eligibility Criteria
You may qualify if:
- Chronic hepatitis B, inactive HBsAg carriers or anti-HBc antibody positive patients with AST, ALT level equal or lower than 2x ULN
- Patient who has systemic rheumatic disease for which anti-TNFα treatment indication has been approved by the KFDA; rheumatoid arthritis (RA, 1987 ACR criteria), ankylosing spondylitis (AS, modified New York criteria), psoriatic arthritis (PsA, modified ESSG criteria), and juvenile rheumatoid arthritis (JRA, 1977 ACR criteria).
- Patient who is eligible to start anti-TNFα treatment (etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol) due to treatment failure of other DMARDs against underlying RA, AS, PsA, or JRA. Patient who also fully understands that anti-TNFα agent expenses are not covered in this study.
- Patient who is willing and able to comply with the study drug regimen and all other study requirements
- Patient who is willing and able to provide a written informed consent to participate in the study
You may not qualify if:
- Patient who has liver cirrhosis or a history of hepatocellular carcinoma (HCC) or findings suggestive of HCC, such as suspicious foci or elevated serum alpha fetoprotein (AFP)
- Patient who received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
- Patient who has concomitant other chronic viral infection (HCV or HIV)
- Patient who is pregnant or breastfeeding or willing to be pregnant
- A history of chronic infection, recent serious or life-threatening infection. Especially,
- Patient with current clinical or laboratory evidence of active tuberculosis (TB) or latent TB unless there is documentation of prior anti-TB treatment was appropriate in duration according to the Korea Food and Drug Administration (KFDA) guidelines for management of latent TB in patients being treated with biologic agents
- Patient with a history of herpes zoster within 2 months before screening for this study
- Active malignancy or a history of treated malignancy less than 5 years prior to screening
- Patients who are not cooperative or unable to comply with the study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Konkuk University Medical Centercollaborator
- Kyungpook National University Hospitalcollaborator
- Kyunghee University Medical Centercollaborator
- Kyung Hee University Hospital at Gangdongcollaborator
- Gachon University Gil Medical Centercollaborator
- Daegu Catholic University Medical Centercollaborator
- Eulji University Hospitalcollaborator
- SMG-SNU Boramae Medical Centercollaborator
- The Catholic University of Koreacollaborator
- Severance Hospitalcollaborator
- Ajou University School of Medicinecollaborator
- Ewha Womans University Mokdong Hospitalcollaborator
- Inha University Hospitalcollaborator
- Chonnam National University Hospitalcollaborator
- Chonbuk National University Hospitalcollaborator
- Chungnam National University Hospitalcollaborator
- Hallym University Medical Centercollaborator
- Hanyang Universitycollaborator
- Dong-A Universitycollaborator
- Korea University Guro Hospitalcollaborator
Study Sites (22)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Dong-A University, College of Medicine
Busan, South Korea
Daegu Catholic Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejun, South Korea
Daejun Eulji University Hospital
Daejun, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Konkuk University Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Gangdong Hospital
Seoul, South Korea
Kyunghee University Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yeong wook Song, MD, PhD
Division of Rheumatology, Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2012
First Posted
September 27, 2012
Study Start
September 1, 2012
Primary Completion
August 31, 2015
Study Completion
December 31, 2015
Last Updated
March 6, 2017
Record last verified: 2017-03