Status:
UNKNOWN
Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Rheumatoid Arthritis
Hepatitis B Reactivation
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
Brief Summary
Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in hepatitis B inactive carriers and patients with past HBV infection
Detailed Description
The risk of HBV reactivation is associated with the intensity of immunosuppression. Biological therapies block the action of biological products involved in immune-inflammatory pathogenesis of many di...
Eligibility Criteria
Inclusion
- Age : from 20 to 90 y/o.
- HBsAg-positive for more than 6 months and HBV DNA \< 2000 IU/ml (Subgroup 1）or HBsAg-negative but anti-HBc positive with HBV DNA \< 2000 IU/ml (Subgroup 2）.
- Inflammatory arthritis patients who plan to treat with biological agents, including Humira or Enbrel or Simponi or Orencia or Mabthera or Actemra; as first line biologic treatment is indicated.
Exclusion
- HCV, HIV, or HDV coinfection.
- Uncontrolled HCC or other malignancy within 3 years.
- Decompensated liver cirrhosis (CTP score ≥ 7).
- Uremia patients under hemodialysis or continuous ambulatory peritoneal dialysis or patients with Ccr \< 50 mL/min
- Pregnant or breastfeeding women.
- Women of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug.
Key Trial Info
Start Date :
September 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01907230
Start Date
September 10 2013
End Date
December 31 2019
Last Update
March 13 2019
Active Locations (1)
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1
Division of Gastroenterology & Division of Allergy Immunology and Rheumatology, Taipei Veterans General Hospital
Taipei, Taiwan, 11217