Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection

NCT00371150 | Completed Phase 4 Results

• 1 other identifier: AI463-085
• Study Type: interventional
• Target: 131
• Locations: 5 countries
• Sites: 27

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.

Conditions

Hepatitis B Infection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48

  HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately \<300 copies/mL.

  Week 48 of ETV treatment

Secondary Outcomes (13)

• Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48

  Week 48

• Percentage of Participants With HBV DNA by PCR Category at Week 48

  Week 48

• Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV

  through Week 48

• Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48

  Week 48

• Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)

  Week 48

Study Arms (1)

Arm1

EXPERIMENTAL

Drug: Entecavir

Interventions

Entecavir DRUG

Tablets, Oral, 0.5 mg, once daily, up to 52 weeks

Also known as: Baraclude, BMS-200475

Arm1

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:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (27)

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, 36116, United States

Location

University Of Arizona

Tucson, Arizona, 85724, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

University Of Miami

Miami, Florida, 33136, United States

Location

Empire International Research

Miami, Florida, 33144, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Banks Hepatology Institute, Pc

College Park, Maryland, 20740, United States

Location

Brigham And Women'S Hospital

Boston, Massachusetts, 02115, United States

Location

L L C Bda The Research Institute

Springfield, Massachusetts, 01107, United States

Location

Va New York Harbor Healthcare System

New York, New York, 10010, United States

Location

Westchester Digestive Disease Group, Llp

Yonkers, New York, 10701, United States

Location

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Hunter Holmes Mcguire D V A M C

Richmond, Virginia, 23249, United States

Location

Local Institution

Salvador, Estado de Bahia, 40110, Brazil

Location

Local Institution

Belo Horizonte - Mg, Minas Gerais, 30150, Brazil

Location

Local Institution

Rio de Janeiro - Rj, Rio de Janeiro, 20210, Brazil

Location

Local Institution

Campinas, São Paulo, 13083, Brazil

Location

Local Institution

Sao Paulo - Sp, São Paulo, 01246, Brazil

Location

Local Institution

Guadalajara, Jalisco, 44270, Mexico

Location

Local Institution

Guadalajara, Jalisco, 44280, Mexico

Location

Local Institution

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution

Zapopan, Jalisco, 45150, Mexico

Location

Local Institution

Df, Mexico City, 14000, Mexico

Location

Local Institution

Santurce, 00909, Puerto Rico

Location

Local Institution

Belville, Western Cape, 7350, South Africa

Location

Local Institution

Goodwood, Western Cape, 7460, South Africa

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: September 1, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 16, 2012
• Results First Posted: April 16, 2012

Record last verified: 2012-03

Locations

US (14); ZA (2); ME (5); BR (5); PR (1)