Thrombocytopenia caused by hepatitis-C
Conditions
Sponsors
GlaxoSmithKline Research and Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 year). • 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% per year. TPL102357 27 • 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Platelet count (between 20,000 and < 70,000/uL) to = 100,000/uL after 4 weeks of administration of SB-497115-GR prior to receiving antiviral therapy. ; Main Objective: 1. To evaluate the effects of SB-497115-GR on platelet counts when administered once daily for 4 weeks to subjects with chronic hepatitis C-related thrombocytopenia, prior to receiving antiviral therapy. ; Secondary Objective: 1. To evaluate the effects of SB-497115-GR on platelet counts when administered once daily for 8 weeks to subjects with chronic hepatitis C-related thrombocytopenia, during antiviral therapy. 2. To evaluate the pharmacodynamic effects of SB-497115-GR on markers of thrombopoiesis, when administered once daily for 12 weeks to subjects with chronic hepatitis C-related thrombocytopenia. 3. To evaluate the effects of SB-497115-GR on antiviral treatment outcome measures during and after antiviral therapy in subjects with chronic hepatitis C. 4. To evaluate the safety and tolerability of SB-497115-GR when administered once daily for 12 weeks to subjects with chronic hepatitis C. 5. To evaluate the population pharmacokinetic profile of SB-497115-GR when administered once daily for 12 weeks to subjects with chronic hepatitis C. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed