Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFa

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01694264
• Date of registration: 24/09/2012
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFa
• Scientific title: 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-TNFa Treatment
• Date of first enrolment: September 1, 2012
• Target sample size: 43
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01694264
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Yeong wook Song, MD, PhD
• Affiliation: Division of Rheumatology, Seoul National University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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-TNFa 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-TNFa 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-TNFa 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

Exclusion Criteria:

- 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

- Patients with any other condition which the investigator's judgment would make the
patient unsuitable for inclusion in the study such as alcohol and drug abuse



Age minimum: 16 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Rheumatoid Arthritis

Ankylosing Spondylitis

Psoriatic Arthritis

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Entecavir

Drug: Placebo

Primary Outcome(s)

The frequency (events) of HBV reactivation [Time Frame: 48 weeks]

Secondary Outcome(s)

Incidence of HBV reactivation among different anti-TNFa treatment groups [Time Frame: 72 weeks]

Secondary ID(s)

H-1112-073-390

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hanyang University

Kyungpook National University

SMG-SNU Boramae Medical Center

Chungnam National University Hospital

Konkuk University Medical Center

Kyunghee University Medical Center

Severance Hospital

Dong-A University

Korea University Guro Hospital

Chonbuk National University Hospital

The Catholic University of Korea

Ajou University School of Medicine

Daegu Catholic University Medical Center

Ewha Womans University Mokdong Hospital

Hallym University Medical Center

Inha University Hospital

Kyung Hee University Hospital at Gangdong

Chonnam National University Hospital

Eulji University Hospital

Gachon University Gil Medical Center