Clinical trial · Interventional
Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients
Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial
NCT01907230CI-TRIAL-00037568unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in hepatitis B inactive carriers and patients with past HBV infection
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exposure to Hepatitis B Virus | — | UNRESOLVED | — |
| Hepatitis B Reactivation | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Entecavir, Prophylactic group
- description
- Participants will initiate entecavir 0.5 mg/day orally one week before biologic treatment. Entecavir treatment will be continued normally for 12 months (6 months after stopping biologic therapy or till restart another course of biologic treatment if the clinicians' judgment is minimal risk of reactivation after the first course of biologic agent treatment).
- interventionNames
- Drug: Entecavir
- type
- NO_INTERVENTION
- label
- Control group (pre-emptive treatment)
- description
- Patients will start entecavir therapy, 0.5 mg/day orally, when reactivation of HBV (defined as detectable HBV viral loads for 2 consecutive visits with at least one month apart), and continued entecavir treatment until undetectable HBV viral loads for 1 year (consistent with current APASL recommendation).
Primary outcomes (1)
- measure
- HBV reactivation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age : from 20 to 90 y/o. 2. 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）. 3. 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: 1. HCV, HIV, or HDV coinfection. 2. Uncontrolled HCC or other malignancy within 3 years. 3. Decompensated liver cirrhosis (CTP score ≥ 7). 4. Uremia patients under hemodialysis or continuous ambulatory peritoneal dialysis or patients with Ccr \< 50 mL/min 5. Pregnant or breastfeeding women. 6. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.