A Randomized, Double-Blind Trial of Telbivudine (LdT) versus Continued Lamivudine Treatment in Adults with Compensated Chronic Hepatitis B Who are Currently Receiving Lamivudine Treatment
- Conditions
- chronic hepatitis B
- Registration Number
- EUCTR2004-003754-26-ES
- Lead Sponsor
- Idenix Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
Patients must meet all of the following inclusion criteria:
Male or female, 18 to 70 years of age
Documented compensated chronic hepatitis B defined by all of the following:
• Clinical history compatible with compensated chronic hepatitis B
• Detectable serum HBsAg at the Screening visit
• HBeAg seropositive or seronegative
• History of evidence of chronic liver inflammation, documented by previous history
of elevated serum ALT and/or AST levels (at least two elevated ALT or AST values
spanning six months or more, documented in available records), and/or chronic
liver inflammation documented on previous liver biopsy with available pathology
report.
• Serum ALT level at Screen < 10 x ULN
• Serum HBV DNA > 3 log10 copies/mL by the COBAS Amplicor HBV PCR assay at
the central study laboratory
Patient is currently receiving lamivudine treatment for his/her hepatitis B, and has
received lamivudine continuously for a duration of at least 12 weeks (3 months) and
not more than one year (12 months). The start of lamivudine therapy must be
documented in the patient’s available medical records.
Patient is willing and able to comply with the study drug regimen and all other study
requirements.
The patient is willing and able to provide written informed consent to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patient is pregnant or breastfeeding.
Patient is of childbearing potential (men and women) and unwilling to use a barrier
method of contraception. It is required that a barrier method of contraception be
used (i.e. condom with spermicide or diaphragm with spermicide) by patients of
childbearing potential (men and women) regardless of whether a hormonal agent
also is used as a method of contraception.
Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or
HIV-2. Patients will be tested for antibodies to HCV, HIV, and HDV in the
Screening assessments performed at the central laboratory.
Patient previously received antiviral treatment for hepatitis B other than lamivudine
in the preceding 12 months. Precluded therapies include, but are not limited to,
the following: interferon alpha-, beta-, or gamma-interferon), adefovir dipivoxil or
other PMEA analogs (tenofovir, MCC-478), ganciclovir, ribavirin, entecavir, emtricitabine (FTC), L-FMAU, L-Fd4C, or other investigational anti-HBV
nucleosides/nucleotides.
Patient has received other systemic immunomodulatory treatment for HBV infection in the preceding 12 months. Precluded therapies include, but are not limited to any exposure to thymosin, IL-12, or other putative systemic immunomodulators.
Patient has a medical condition that requires prolonged or frequent use of systemic
acyclovir or famciclovir. Prolonged use means episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
A history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of hepatic decompensation.
Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha-fetoprotein (AFP) levels. In patients with such findings, HCC should be ruled-out prior to randomization for the present study.
Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse
or illicit substance abuse within the preceding two years. For the purposes of the
present study, alcohol abuse is defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40 g of ethanol. Patients
currently on methadone maintenance treatment programs are NOT eligible for this
study due to potential interference with study evaluations.
Patient has a medical condition that requires frequent or prolonged use of systemic
corticosteroids
Patient has one or more additional known primary or secondary causes of liver
disease, other than hepatitis B. Gilbert’s syndrome and Dubin-Johnson syndrome, two benign disorders associated with low-grade hyberbilirubinemia, will not exclude patients from participation in this trial. The presence of either of these two disorders should be so indicated on the appropriate page in the case report form.
Patient has any other concurrent medical condition likely to preclude compliance
with the schedule of evaluations in the protocol, or likely to confound the efficacy or
safety observations of the study (e.g., concurrent malignancies, history of unstable
angina, repeated myocardial infarction or congestive heart failure, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current trea
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method