Phase 4
Completed N=46
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
Hepatitis B Infection
Source: ClinicalTrials.gov NCT00371150 ↗
Enrolled (actual)
46
Serious AEs
8.7%
Results posted
Apr 2012
Primary outcomePrimary: Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 — 72.5; 69.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 |
72.5; 69.6 | — |
| SECONDARY Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 |
12.5; 13.0 | — |
| SECONDARY Percentage of Participants With HBV DNA by PCR Category at Week 48 |
72.5; 69.6; 0; 0; 10.0; 10.9 | — |
| SECONDARY Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV |
0; 0 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 |
67.5; 67.4 | — |
| SECONDARY Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only) |
50.0; 53.8 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only) |
40.9; 46.2 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 |
5.0; 6.5 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion at Week 48 |
2.5; 4.3 | — |
| SECONDARY Mean log10 Reduction From Baseline in HBV DNA at Week 48 |
7.1; 7.0; 1.88; 1.87; -5.22; -5.18 | — |
| SECONDARY Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis |
— | — |
| SECONDARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events |
0; 0; 0; 3; 1; 4 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology |
1; 2; 0; 0; 15; 18 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry |
37; 43; 3; 4; 33; 38 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00371150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.