Clinical trial NCT00395018: Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Official title: Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Keywords: Chronic Hepatitis B Virus, Liver Transplant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 109
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72
timeFrame: At 72 weeks
measure: Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
timeFrame: At baseline (day 1), week 12, 24, 36, 48, 60, and 72
Secondary outcomes:
measure: Distribution of ALT Levels Through 72 Weeks: Overall
timeFrame: On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72
measure: Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up
timeFrame: At 72 weeks + 24 weeks follow-up
measure: Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)
timeFrame: At week 72
measure: Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)
timeFrame: At week 72
measure: Percentage of Participants With HBsAg Loss at Week 72
timeFrame: At week 72
measure: Percentage of Participants With HBsAg Seroconversion at Week 72
timeFrame: At week 72
measure: Percentage of Participants With HBsAg Recurrence At Week 72
timeFrame: At week 72
measure: Total Bilirubin at Week 72
timeFrame: At week 72
measure: Prothrombin Time (PT) at Week 72
timeFrame: At week 72
measure: Number of Participants With Liver Rejection Through Week 72
timeFrame: Through week 72
measure: Number of Participants With Re-transplantation Through Week 72
timeFrame: Through week 72
measure: Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
timeFrame: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up
measure: Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
timeFrame: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up
measure: Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
timeFrame: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinic
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: Rochester
country: United States
facility: University Of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: University Of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Paris Cedex 12
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torrette Di Ancona
country: Italy
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: