Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Other anti-HBV medication; Drug: entecavir

• Registration Number: NCT00388674
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-04
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Study Start: 2006-12-18
• Primary Completion: 2016-10-26
• Study Completion: 2016-10-26
• Status Verified: 2017-10
• Results First Submitted: 2017-10-25
• Results First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Results First Posted: 2018-07-30
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12522

Inclusion Criteria

• Chronic HBV infection
• HBV nucleoside/tide-naive or -experienced
• Patients who, in opinion of investigator, are appropriate for initiating or modifying their HBV therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either ETV or another standard of care HBV nucleoside/tide analogue
• Age 16 and older or minimum age required in a given country

Exclusion Criteria

• Women who are pregnant or breastfeeding

• Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year

• Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance

• Coinfection with HIV

• History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers

• Patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing ETV:

  i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution

• History of dysplastic liver nodules

• Known history of allergy to nucleoside/tide analogues

• Prior or current treatment with entecavir

• An investigator proposed study regimen which will include only interferon-alfa

• An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	Other anti-HBV medication	-
A	entecavir	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adjudicated Overall Malignant Neoplasms	10 years	The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Number of Deaths	10 years	The number of deaths, as adjudicated by Events Adjudication Committee (EAC)
Number of Participants With Liver-related HBV Disease Progression	10 years	The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With HCC Malignant Neoplasm	10 years	The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Number of Participants With Non-HCC Malignant Neoplasm	10 years	The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Number of Participants With Liver-related Death	10 years	The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)

Trial Locations

Locations (21)

Office Of Sing Chan Md; 🇺🇸 Flushing, New York, United States

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Scti Research Foundation; 🇺🇸 Coronado, California, United States

Kaiser Permanente Medical Center; 🇺🇸 San Francisco, California, United States

Va New York Harbor Healthcare System; 🇺🇸 New York, New York, United States

Local Institution; 🇹🇷 Trabzon, Turkey

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Cedars-Sinai Comprehensive Transplant Center; 🇺🇸 Los Angeles, California, United States

University Of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Medical Procare, Pllc; 🇺🇸 Flushing, New York, United States

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

University Of Miami Center For Liver Diseases; 🇺🇸 Miami, Florida, United States

Integris Baptist Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Tulane University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Phgi Associates, Ltd; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson Medical College; 🇺🇸 Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Rush University Med Ctr; 🇺🇸 Chicago, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Upmc Center For Liver Diseases; 🇺🇸 Pittsburgh, Pennsylvania, United States