SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. Approximately 169 patients will be randomized to either SB497115 or placebo. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/uL for Pegasys and platelet count 100,000/uL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

Condition	Treatment or Intervention	Phase
Hepatitis C Thrombocytopenia	Drug: SB497115	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Written informed consent.
• Chronic low platelet count between 20,000 and <70,000/uL.
• 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.
• No history of heart attack or abnormal heart function.
• Prothrombin time (PT) < 5 seconds prolonged or an (International Normalized Ratio) INR < 1.6 seconds of the normal reference range.
• Use of acceptable contraceptives.

Exclusion criteria:

• History of thrombosis within 1 year.
• Females who are pregnant.
• History of alcohol or drug abuse or dependence within 1 year.
• Treatment with an investigational drug within 30 days.
• Use of aspirin, aspirin-containing compounds, salicylates, milk of magnesia, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
• Use of herbal/dietary supplements (excluding vitamins and mineral supplements) within 1 week of study start.
• History of platelet aggregation that would prevent measurement of platelet counts.
• History of HIV infection; active infection with Hepatitis B or C.

Please refer to this study by ClinicalTrials.gov identifier  NCT00110799

California
      Los Angeles,  California,  90033,  United States; Not yet recruiting
      Pasadena,  California,  91105,  United States; Recruiting
Colorado
      Denver,  Colorado,  80262,  United States; Not yet recruiting
Illinois
      Chicago,  Illinois,  60612,  United States; Not yet recruiting
Massachusetts
      Boston,  Massachusetts,  02215,  United States; Not yet recruiting
Michigan
      Detroit,  Michigan,  48202,  United States; Not yet recruiting
Missouri
      St. Louis,  Missouri,  63104,  United States; Not yet recruiting
New York
      New York,  New York,  10021,  United States; Not yet recruiting
North Carolina
      Durham,  North Carolina,  27710,  United States; Not yet recruiting
Virginia
      Richmond,  Virginia,  23298,  United States; Recruiting
Greece
      Athens,  115 26,  Greece; Not yet recruiting
      Athens,  115 27,  Greece; Not yet recruiting
      THESSALONIKI,  546 36,  Greece; Not yet recruiting
      THESSALONIKI,  546 42,  Greece; Not yet recruiting
      THESSALONIKI,  564 29,  Greece; Not yet recruiting
Greece, Patras
      Rio,  Patras,  265 04,  Greece; Not yet recruiting
United Kingdom
      Bristol,  BS2 8HW,  United Kingdom; Not yet recruiting
      Edinburgh,  EH16 4SA,  United Kingdom; Not yet recruiting
      Glasgow,  G12 0YN,  United Kingdom; Not yet recruiting
      Nottingham,  NG7 2UH,  United Kingdom; Not yet recruiting

Study ID Numbers:  TPL102357
Record last reviewed:  May 2005
Last Updated:  May 13, 2005
Record first received:  May 13, 2005
ClinicalTrials.gov Identifier:  NCT00110799
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17