Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients

NCT01907230 | Unknown Phase 4

• 1 other identifier: AI463-962
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis; Hepatitis B Reactivation; Exposure to Hepatitis B Virus

Keywords

Rheumatoid arthritis; Inactive HBV carrier; Resolved Hepatitis B; HBV reactivation; Anti-tumor necrotic factor-alfa

Outcome Measures

Primary Outcomes (1)

• HBV reactivation

  The main goal of the study is to delineate the incidence of HBV reactivation during and after biologic treatment in IA patients who are inactive HBV carriers or have past HBV infection, and tries to define the optimal HBV monitoring and antiviral prophylactic strategy in IA patients.

  12 months after biologic treatment

Secondary Outcomes (2)

• HBsAg reverse seroconversion in occult HB patients.

  12 months after biologic treatment

• Hepatitis flare (ALT > 100 U/L) related to biological treatments

  12 months after biologic treatment

Study Arms (2)

Entecavir, Prophylactic group

EXPERIMENTAL

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).

Drug: Entecavir

Control group (pre-emptive treatment)

NO INTERVENTION

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).

Interventions

Entecavir DRUG

In the prophylactic group, participants will initiate entecavir 0.5 mg/day orally one week before biologic treatment. Entecavir treatment (adjust dosage according to renal function) 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).

Also known as: Baraclude

Entecavir, Prophylactic group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Division of Gastroenterology & Division of Allergy Immunology and Rheumatology, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

entecavir

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yi-Hsiang Huang, MD, Ph.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Yi-Hsiang Huang

Study Record Dates

• First Submitted: July 14, 2013
• First Posted: July 24, 2013
• Study Start: September 10, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

TW (1)