Status:
UNKNOWN
Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Chronic Hepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication, histology improvement as well as low rate of emergence of resistant mutants. Out of range of clinical recomm...
Detailed Description
TITLE : A Randomized, Double-blind, Placebo-control Study Evaluating the Efficacy of Entecavir in Patients with Chronic Hepatitis B Virus Infection and Persistently Normal Alanine Aminotransferase IND...
Eligibility Criteria
Inclusion
- Male and female subjects aged between 18 and 65 year-old with history of chronic hepatitis B virus infection;
- Detectable HBsAg at screening and for at least 24 weeks prior to screening or detectable HBsAg for \< 24 week and negative for IgM core antibody and confirmation of chronic hepatitis on liver biopsy;
- ALT should be within normal range in recent one year and at least twice, which are at least 3 month apart;
- Normal ALT at screening;
- Screening HBV DNA of more than 10\^5 copies/mL by Roche AmplicorTM PCR assay performed by the central laboratory;
- Evidence of chronic hepatitis on liver biopsy (Knodell HAI Score \>= 4) performed ≤ 52 weeks prior to randomization;
- All women of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion
- Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV);
- Other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
- Patients with evidence of decompensation of liver disease;
- Therapy with interferon, thymosin alpha or antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir, lamivudine, and telbivudine) within 24 weeks of randomization into this study;
- More than 12 weeks of prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir lamivudine, and telbivudine);
- Prior therapy with entecavir;
- Known history of allergy to nucleoside analogues;
- Hemoglobin \< 10.0 g/dL;
- Platelet count \< 75,000/mm3;
- Absolute neutrophil count\< 1500 cells/mm3;
- Creatinine \> 1.5mg/dL (133 μmol/L);
- Anti-nuclear antibody (ANA) titer \> l :160 unless attributable to non-hepatic disease.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01833611
Start Date
September 1 2008
End Date
May 1 2015
Last Update
April 17 2013
Active Locations (4)
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1
Buddhist Dalin Tzu-Chi General Hospital
Chiayi City, Taiwan
2
Chia-Yi Christian Hospital
Chiayi City, Taiwan
3
Chang-Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
4
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan