EUCTR2004-003754-26-GB进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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? no
- •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
排除标准
- •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
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