Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

NCT00395018 | Completed Phase 3 Results

• 1 other identifier: AI463-109
• Study Type: interventional
• Target: 109
• Locations: 9 countries
• Sites: 32

Brief Summary

The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

Conditions

Hepatitis B, Chronic

Keywords

Chronic Hepatitis B Virus, Liver Transplant

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72

  HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.

  At 72 weeks

• Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72

  HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.

  At baseline (day 1), week 12, 24, 36, 48, 60, and 72

Secondary Outcomes (14)

• Distribution of ALT Levels Through 72 Weeks: Overall

  On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72

• Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up

  At 72 weeks + 24 weeks follow-up

• Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)

  At week 72

• Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)

  At week 72

• Percentage of Participants With HBsAg Loss at Week 72

  At week 72

Study Arms (1)

entecavir

EXPERIMENTAL

Drug: entecavir

Interventions

entecavir DRUG

Tablets, Oral, 1 mg, once daily, up to 72 weeks

Also known as: Baraclude, BMS-200475

entecavir

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA \< 172 IU/mL (approximately \< 1000 copies/mL) prior to liver transplant
• Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening

You may not qualify if:

• Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
• Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (32)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Tulane University Hospital & Clinic

New Orleans, Louisiana, 70112, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University Of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University Of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Baylor College Of Medicine

Houston, Texas, 77030, United States

Location

Local Institution

Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Local Institution

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution

Heidelberg, Victoria, 3084, Australia

Location

Local Institution

Fortaleza, Ceará, 60430, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90035, Brazil

Location

Local Institution

São Paulo, São Paulo, 01246, Brazil

Location

Local Institution

Clichy, 92118, France

Location

Local Institution

Paris, 75571, France

Location

Local Institution

Villejuif, 94800, France

Location

Local Institution

Bologna, 40125, Italy

Location

Local Institution

Roma, 00133, Italy

Location

Local Institution

Roma, 00168, Italy

Location

Local Institution

Torrette Di Ancona, 60020, Italy

Location

Local Institution

Seoul, 110-744, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 138-736, South Korea

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Barcelona, 08036, Spain

Location

Local Institution

Madrid, 280009, Spain

Location

Local Institution

Valencia, 46009, Spain

Location

Local Institution

Kaohsiung City, 833, Taiwan

Location

Local Institution

Taipei, 112, Taiwan

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: April 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 31, 2012
• Results First Posted: May 31, 2012

Record last verified: 2012-04

Locations

ES (4); TW (2); KR (4); AU (2); BR (3); AR (1); FR (3); IT (4); US (9)