Comparative study in childrens with chronic Hepatitis B virus infection who are HBeAg positive.
- Conditions
- Health Condition 1: null- Pediatric Subjects ( 12 to 18 yrs ) with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-Positive
- Registration Number
- CTRI/2011/09/002001
- Lead Sponsor
- The pharmaceutical company sponsoring this study is BristolMyers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
1) Signed Written Informed Consent
a) Freely given informed consent must be obtained prior to clinical trial
participation, including informed consent for any screening procedures conducted
to establish subject eligibility for the trial. Minor?s parents or legally acceptable
representatives must give fully informed written consent. Assent should be
obtained when the minor is judged to be of an age of reason (see Appendix 1);
2) Target Population
a) History of CHB infection defined as HBsAg-positive at the Screening visit and on
at least one other occasion ≥ 24 weeks prior to screening;
b) Detectable HBeAg AND no detectable anti-HBe antibodies at screening and at
least once ≥ 4 weeks prior to screening;
c) Serum ALT 1.5 to < 10 x ULN at screening and at least on one other occasion
within 8 to 24 weeks prior to screening;
d) HBV DNA by PCR ≥ 105 copies/mL at screening and evidence of the presence of
HBV DNA at least once ≥ 4 weeks prior to screening;
3) Age and Sex
a) Male and females, 2 to <18 years of age.
Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 6 weeks after
the last dose of investigational product in such a manner that the risk of pregnancy
is minimized.
WOCBP include any female who has experienced menarche and who has not
undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined
as:
? Amenorrhea ≥ 12 consecutive months without another cause or
? For women with irregular menstrual periods and on hormone replacement
therapy (HRT), a documented serum follicle stimulating hormone (FSH) level
> 35 mIU/mL
Women who are using oral contraceptives, other hormonal contraceptives
(vaginal products, skin patches, or implanted or injectable products), or
mechanical products such as an intrauterine device or barrier methods
(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing
abstinence or where their partner is sterile (eg, vasectomy) should be considered
to be of childbearing potential.
WOCBP must have a negative serum or urine pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of HCG) at screening AND within
72 hours prior to the start of investigational product.
Sex and Reproductive Status
a) 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 the last dose of
investigational product
b) WOCBP using a prohibited contraceptive method. At this time there are no
known contraindicated contraceptives to entecavir
c) Women who are pregnant or breastfeeding
d) Women with a positive pregnancy test on enrollment or prior to investigational
product administration
e) Sexually active fertile men not using effective birth control if their partners are
WOCBP
Target Disease Exceptions
a) Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV)
or hepatitis D virus (HDV)
b) Other forms of acute and chronic conditions which may cause increased ALT as
determined by the investigators (eg, acute viral illness, Wilson Disease, other
metabolic disorders, autoimmune hepatitis, alcoholic liver disease)
c) Liver transplant recipients
Medical History and Concurrent Diseases
a) Current evidence of, or history of variceal bleeding, hepatic encephalopathy, or
ascites requiring diuretics or paracentesis or evidence of these on physical
examination performed for this study;
b) Current evidence of, or history of pancreatitis
c) Received bone marrow or organ transplant or therapy with an
immunomodulatory, cytotoxic, or systemic corticosteroid therapies within
2 months of enrollment
d)Evidence of current pre-malignant lesions and malignancies including HCC(to
be excluded by screening and evaluation practices standard in the country of
enrollment)
e)Other serious medical conditions that might preclude completion of this study
4) Physical and Laboratory Test Findings
a) Hemoglobin 10.0 g/dL
b) Platelet count 70,000/mm3
c) Inadequate renal function with estimated glomerular filtration rate of
50 mL/min/1.73m2 d) Total serum bilirubin 2.5 mg/dL ( 42.75 ¦Ìmol/L)
e) INR 1.5
f) Serum albumin 3.0 g/dL ( 30 g/L)
g) Alpha Fetoprotein ¡Ý 50 ng/mL
5) Allergies and Adverse Drug Reactions
a) Known allergy to nucleoside analogues
6) Prohibited Treatments and/or Therapies
a) ¡Ý 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent with
activity against hepatitis B virus (including but not limited to adefovir, tenofovir
famciclovir, clevudine, lamivudine, telbivudine, or emtricitabine)
b) Therapy with interferon alpha, thymosin alpha or any nucleos[t]ide antiviral agent
with activity against hepatitis B virus within 24 weeks of screening
c) Any prior therapy with ETV;
d) Any use of illegal drugs OR use of alcoholic beverages which in the investigator¡¯s
opinion is sufficient to prevent adequate compliance with study procedures or
increase the risk pancreatitis or hepatotoxicty;
e) Concomitant medications which may cause immunosuppression, nephrotoxicity
or hepatotoxicity or affect renal excretion or hepatic metabolism are not
permitted
f) Concomitant use of Traditional Chinese Medicines or other herbal products
purported to have antiviral activity or intended for use in improving/protecting
liver function
g) During the treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method