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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00371150

Purpose

The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in patients who are either of Black/African-American race or of Hispanic ethnicity. (As of July 31, 2009, the recruitment for Black/African Americans was completed.)

Condition	Intervention	Phase
Hepatitis B Infection	Drug: Entecavir	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Entecavir

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The proportion of subjects who achieve a virologic response, defined as HBV DNA < 50 IU/mL (approximately 300 copies/mL) [ Time Frame: at Week 48 of ETV treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the proportions of subjects meeting the following endpoints [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
HBV DNA < lower limit of detection [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Mean reduction from baseline in HBV DNA [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Proportion with ALT normalization (≤ 1 x ULN) [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Proportions with confirmed HBeAg loss and HBe seroconversion; and confirmed HBsAg loss and HBs seroconversion (for HBeAg-positive cohort only) [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Number and percent of subjects with adverse events (AEs), serious AEs (SAEs), laboratory abnormalities and discontinuations due to AEs. [ Time Frame: at Week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	November 2006
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1	Drug: Entecavir Tablets, Oral, 0.5 mg, once daily, up to 48 weeks Other Names: Baraclude BMS-200475

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

As of July 31, 2009, the recruitment for Black/African Americans was completed.

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 (As of July 31, 2009, the recruitment for Black/African Americans was completed)
Nucleoside/tide-naive
Males or females ≥ 16 years of age (or minimum age required in a given country)
Compensated liver function
HBV DNA HBe-negative > 10^4 copies/mL HBe-positive > 10^5 copies/mL
ALT of 1.3 to 10 x ULN
No Co-infection with HIV, HCV or HDV

Exclusion Criteria

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
Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV; coinfection is defined as HCV Ab positive with detectable HCV ribonucleic acid [RNA] by PCR) or hepatitis D virus (HDV)
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, LVD, ADV, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371150

Show 27 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00371150 History of Changes
Other Study ID Numbers:	AI463-085
Study First Received:	August 29, 2006
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012