Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα (NCT01694264) | Clinical Trial Compass
TerminatedPhase 3
Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα
Stopped: Delayed recruitment, unable to meet calculated sample size
South Korea43 participantsStarted 2012-09-01
Plain-language summary
Analysis of effect of anti-TNFα treatment on HBV reactivation among patients with systemic rheumatic disease, especially rheumatoid arthritis
Who can participate
Age range16 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-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
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 infe…