Clinical trial NCT00371150: Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
Official title: A Study to Describe the Antiviral Effect of Entecavir (ETV) in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection Who Are Nucleoside-Naive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 131
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: TREATMENT

Brief summary: The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.


Eligibility criteria: Inclusion Criteria:

* Chronic HBV infection, with either HBeAg-positive (HBeAb-negative) or HBeAg-negative (HBeAb-positive) disease
* Black/African American Race and/or Hispanic ethnicity
* Nucleoside/tide-naive
* Males or females ≥ 16 years of age (or minimum age required in a given country)
* Compensated liver function
* ALT of 1.3 to 10 x upper limit of normal (ULN)
* No Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV)

Exclusion Criteria

* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after study medication has been discontinued
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to study drug administration
* Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis
* Recent history of pancreatitis (resolution of any recent pancreatitis must be documented by normal lipase at least 12 weeks prior to the first dose of study medication)
* Currently abusing illegal drugs or alcohol sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
* Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
* Serum creatinine \> 1.5 mg/dL
* Hemoglobin \< 10.0 g/dL
* Platelet count \< 70,000/mm3
* Absolute neutrophil count \< 1200 cells/mm3
* Serum alpha fetoprotein (AFP) level \> 100 ng/mL. If the AFP level is between 21 and 100 ng/mL, it must be repeated. If the repeat AFP level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma, the subject may be dosed in the study
* Known history of allergy to nucleoside analogues
* Any prior therapy with Entecavir
* Any prior or concomitant use of nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., ETV, lamivudine (LVD), tenofovir \[TDF\], emtricitabine (FTC), clevudine, telbivudine \[LdT\], famciclovir), or any other experimental anti-HBV antiviral agent
* Therapy with interferon, thymosin alpha or other immunostimulators within 24 weeks of enrollment (i.e., dosing) into this study
* Subjects who require chronic administration of concomitant medications which cause immunosuppression or which are associated with a high rate of nephrotoxicity or hepatotoxicity, or which affect renal excretion, should not be enrolled in this study
* Unable to tolerate oral medication
* Poor peripheral venous access
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Primary outcomes:
measure: Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48
timeFrame: Week 48 of ETV treatment
Secondary outcomes:
measure: Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HBV DNA by PCR Category at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV
timeFrame: through Week 48
measure: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)
timeFrame: Week 48
measure: Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)
timeFrame: Week 48
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HBsAg Seroconversion at Week 48
timeFrame: Week 48
measure: Mean log10 Reduction From Baseline in HBV DNA at Week 48
timeFrame: baseline, Week 48
measure: Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis
timeFrame: Week 48
measure: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events
timeFrame: From enrollment through Week 52 + 5 days
measure: Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology
timeFrame: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up
measure: Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry
timeFrame: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: Tucson
country: United States
facility: University Of Arizona
state: Arizona
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Miami
country: United States
facility: Empire International Research
state: Florida
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: College Park
country: United States
facility: Banks Hepatology Institute, Pc
state: Maryland
city: Boston
country: United States
facility: Brigham And Women'S Hospital
state: Massachusetts
city: Springfield
country: United States
facility: L L C Bda The Research Institute
state: Massachusetts
city: New York
country: United States
facility: Va New York Harbor Healthcare System
state: New York
city: Yonkers
country: United States
facility: Westchester Digestive Disease Group, Llp
state: New York
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes Mcguire D V A M C
state: Virginia
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Belo Horizonte - Mg
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Rio De Janeiro - Rj
country: Brazil
facility: Local Institution
state: Rio De Janeiro
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo - Sp
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Santurce
country: Puerto Rico
facility: Local Institution
city: Belville
country: South Africa
facility: Local Institution
state: Western Cape
city: Goodwood
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: