UnknownPhase 4

Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients

Taiwan115 participantsStarted 2013-09-10

Plain-language summary

Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in hepatitis B inactive carriers and patients with past HBV infection

Who can participate

Age range20 Years – 90 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

HBV reactivation

Timeframe: 12 months after biologic treatment

Trial details

NCT IDNCT01907230

SponsorTaipei Veterans General Hospital, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2018-12-31

View on ClinicalTrials.gov More Rheumatoid Arthritis trials