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Hepatitis B InfectionPhase 4NCT00371150

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

A Phase 4 study testing Entecavir in people with Hepatitis B Infection, run by Bristol-Myers Squibb at 27 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Hepatitis B Infection
What is being tested?
Entecavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
27 sitesin 5 countries
Study dates
Nov 2006to Mar 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

27 sites in 5 countries.

27 sites in 5 countries

United States14 sites

  • Brigham And Women'S Hospital

    Boston, Massachusetts, 02115

  • University Of Chicago

    Chicago, Illinois, 60637

  • Banks Hepatology Institute, Pc

    College Park, Maryland, 20740

  • University Of Miami

    Miami, Florida, 33136

  • Empire International Research

    Miami, Florida, 33144

  • Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, 36116

  • Va New York Harbor Healthcare System

    New York, New York, 10010

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • Hunter Holmes Mcguire D V A M C

    Richmond, Virginia, 23249

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • L L C Bda The Research Institute

    Springfield, Massachusetts, 01107

  • University Of Arizona

    Tucson, Arizona, 85724

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Westchester Digestive Disease Group, Llp

    Yonkers, New York, 10701

Other trials in United States

Brazil5 sites

  • Local Institution

    Belo Horizonte - Mg, Minas Gerais, 30150

  • Local Institution

    Campinas, São Paulo, 13083

  • Local Institution

    Rio de Janeiro - Rj, Rio de Janeiro, 20210

  • Local Institution

    Salvador, Estado de Bahia, 40110

  • Local Institution

    Sao Paulo - Sp, São Paulo, 01246

Other trials in Brazil

Mexico5 sites

  • Local Institution

    Df, Mexico City, 14000

  • Local Institution

    Guadalajara, Jalisco, 44270

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    Guadalajara, Jalisco, 44650

  • Local Institution

    Zapopan, Jalisco, 45150

Other trials in Mexico

South Africa2 sites

  • Local Institution

    Belville, Western Cape, 7350

  • Local Institution

    Goodwood, Western Cape, 7460

Other trials in South Africa

Puerto Rico1 site

  • Local Institution

    Santurce, 00909

Other trials in Puerto Rico

About this study

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

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.

Being tested
Entecavir
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntecavirDrug

    Also called Baraclude, BMS-200475

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

Study groups in NCT00371150
Study groupRoleWhat they receive
Arm1ExperimentalNot described
Receives: Drug: Entecavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48 of ETV treatment

Secondary outcomes (13)

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

    HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.

    Measured: Week 48

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

    HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.

    Measured: Week 48

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

    Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)

    Measured: through Week 48

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

    ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.

    Measured: Week 48

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

    HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week

    Measured: Week 48

  6. Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)

    HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).

    Measured: Week 48

  7. Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

    HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.

    Measured: Week 48

  8. Percentage of Participants With HBsAg Seroconversion at Week 48

    HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.

    Measured: Week 48

  9. Mean log10 Reduction From Baseline in HBV DNA at Week 48

    HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.

    Measured: baseline, Week 48

  10. Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis

    Measured: Week 48

  11. Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events

    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.

    Measured: From enrollment through Week 52 + 5 days

  12. Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology

    Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.

    Measured: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up

  13. Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry

    The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:>1.25xULN, Aspartate aminotransferase:>1.25xULN, Alkaline Phosphatase:>1.25xULN, Total Bilirubin:>1.1xULN, Serum Lipase:>1.10xULN, Creatinine:>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L

    Measured: OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00371150
Sponsor's protocol ID
AI463-085
Status last verified
Mar 2012
First submitted
29 Aug 2006
Last updated
16 Apr 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entecavir in people with Hepatitis B Infection, run by Bristol-Myers Squibb at 27 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Brazil, Mexico, South Africa, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 (time frame: Week 48 of ETV treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00371150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2012.

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