EUCTR2004-001469-16-GB进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, multi-centre, dose-ranging, parallel group, phase II study to assess efficacy, safety/tolerability, and pharmacokinetics of a thrombopoietin receptor agonist, SB-497115-GR, when administered as 30, 50, and 75 mg once daily for 12 weeks in subjects with chronic hepatitis C–related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin.
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 0 人开始时间: 2005年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1. Male and female subjects with detectable hepatitis C virus antibodies and RNA who
- •are potential candidates for pegylated interferon alpha-based antiviral therapy.
- •2. Prior liver biopsy indicating chronic hepatitis within the previous 5 years or
- •radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding
- •esophageal or gastric varices.
- •3. Platelet count 20,000 to < 70,000 platelets/uL.
- •4. Absolute neutrophil count (ANC) = 1000/mm3
- •5. Hemoglobin concentration > 11.0 gm/dL.
- •6. Prothrombin time (PT) < 5 seconds prolonged or an INR < 1.6 seconds of the normal
- •reference range.
- •7. Normal 12-lead ECG at screening, no past history of myocardial infarction or
- •clinically significant abnormal ECGs.
- •8. Male and females subjects = age 18.
- •9. A female is eligible to enter and participate in the study if she is of:
- •Non-childbearing potential (i.e., physiologically incapable of becoming
- •pregnant) including any female who:
- •Has had a hysterectomy,
- •Has had a bilateral oophorectomy (ovariectomy)
- •Has had a bilateral tubal ligation, or
- •Is post-menopausal (demonstrate total cessation of menses for greater than 1
- •Childbearing potential, has a negative serum pregnancy test at screening, and
- •uses adequate contraception. GSK acceptable contraceptive methods, when
- •used consistently and in accordance with both the product label and the
- •instructions of the physician, are as follows:
- •Complete abstinence from intercourse for 2 weeks before exposure to the study
- •drug, throughout the clinical trial, and for a period after the trial to account for
- •the elimination of the study drug (minimum of 5 half-lives).
- •Any intrauterine device (IUD) with a documented failure rate of less than 1%
- •Double-barrier contraception (condom with spermicidal jelly, foam suppository,
- •or film; diaphragm with spermicide; or male condom and diaphragm).
- •Male partner who is sterile prior to the female patient’s entry and is the sole
- •sexual partner for that female.
- •Oral contraceptive (either combined or progesterone only).
- •10. Serum creatinine concentration < 1.5 x upper limit of normal range.
- •11. Serum bilirubin concentration = 2 mg/dl unless due to documented Gilbert's disease.
- •12. Free of clinical ascites.
- •13. No history of bleeding varices.
- •14. No evidence of hepatocellular carcinoma based on a negative baseline ultrasound.
- •15. Subject is able to understand and comply with protocol requirements and instructions
- •and is likely to complete the study as planned.
- •16. Ability to provide written informed consent.
- •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 rang
排除标准
- •1. Subjects with a known hypersensitivity, intolerance or allergy to interferon, ribavirin or any of the ingredients in SB-497115-GR tablets.
- •2. Laboratory evidence of infection with HIV 1/2 or active HBV infection.
- •3. Any disease condition associated with active bleeding or requiring anticoagulation
- •with heparin or warfarin.
- •4. Active infection requiring systemic antibiotic therapy.
- •5. Any malignancy (with the exception of basal or squamous cell carcinoma of the skin
- •if adequately treated and no recurrence for > 1 year).
- •6. History of thrombosis.
- •7. Any other concurrent condition which, in the opinion of the investigator, would
- •preclude participation in or interfere with compliance.
- •8. Pregnant or nursing women.
- •9. History of alcohol/drug abuse or dependence requiring medical intervention within
- •12 months of the study.
- •10. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- •11. Consumption of aspirin, aspirin-containing compounds, salicylates, or nonsteroidal anti-inflammatories (NSAIDs) 7 days prior to the first dose of the study.
- •12. Consumption of antacids or milk of magnesia 48 hours prior to first dose of the study drug
- •13. Consumption of OTC remedies, such as quinine, which are known to affect platelet function.
- •14. History of platelet clumping that prevents reliable measurement of platelet counts.
研究者
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