*To see if you qualify for this Hepatitis C Clinical Trial in
The study will be conducted in three parts. Part A will utilize a randomized group design in treatment-naive, GT!b and 4 HCV-infected subjects. Sixty subjects will be enrolled and randomized to groups of equal size. GT!b and GT4 HCV-infected subjects will be stratified by genotype across the treatment arms. Each group will receive the study drugs for up to 12 weeks followed by a 24-week follow-up to determine sustained virologic response (SVR).
Part B will be a randomized, open-label, parallel-group design in treatment-naive, GT!b, 4 and 6 HCV-infected subjects. Enrollment into Part B will commence following enrollment completion of Part A. GT!b and GT4 HCV-infected subjects will be stratified by genotype between treatment arms in Cohorts I b and 2b. Per Amendment 5, enrollment into the I00 mg RBV-free arm was capped at the number of subjects who had already been dosed into that cohort, and RBV was immediately added to their treatment regimen.
Part C will be an open-label, randomized, parallel group design in treatment-naive or IFN/RBV-treatment relapsed, GT!a and GT!b HCV-infected subjects. An independent DSMB will review the available PK, safety, and antiviral activity data after all subjects have completed 4 weeks of treatment.
BACKGROUND & RATIONALE
Hepatitis C virus (HCV) infection is a global public health problem. The global prevalence of chronic hepatitis C infection is estimated to be approximately 150 million HCV-infected persons worldwide. An estimated 60-70% of chronically infected people develop chronic liver disease; 5-20% develop cirrhosis and 1-5% die from cirrhosis or liver cancer. In 25% of liver cancer patients, the underlying cause is hepatitis C.
This new hepatitis C drug is being developed as a novel, HCV nonstructural protein S A (NSSA) inhibitor agent for the therapy of chronic hepatitis C. This drug acts as a potent inhibitor of HCV replication, inhibiting HCV of Genotypes (GT) l a, l b, 2a, 3a, 4a and Sa in vitro with half maximal effective concentration (ECso) values ranging from 2 to 24 pM, suggesting that it has pan-genotypic activity.
The primary objectives of this study are to evaluate the:
• Safety and tolerability of 2- and 3-drug combinations of the new hepatitis C drug, simeprevir, ritonavir, with or without RBV for up to 12 weeks.
• Efficacy of a 2-DAA combination treatment (new hepatitis drug and simeprevir) with RBV for up to 12 weeks.
• Efficacy of a 3-DAA combination treatment (new hepatitis drug, simeprevir, ritonavir) with or without RBV for up to 12 weeks.
• 18 to 65 years of age, inclusive.
• Female subjects of both childbearing potential and non-childbearing potential may be included, unless the local regulatory authority requires that only females of non childbearing potential be included. Non-childbearing potential is defined as one of the following:
• Postmenopausal, defined as amenorrheic for at least 2 years and serum follicle stimulating hormone (FSH) level consistent with postmenopausal status at Screening, OR
• A documented hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to study initiation.
• All female subjects must have a negative serum beta-human chorionic gonadotropin (P-HCG) at Screening and a negative urine pregnancy test prior to the first dose of study medication on Day J.
• Women of childbearing potential and men must have agreed to use an acceptable double method of birth control (one of which must be a barrier method) from Screening through at least 6 months after the last dose of study drugs.
• The co-administration of RTV with ethinyl estradiol (oral or patch) may result in decreased contraceptive effectiveness. Women in Part C who are receiving estrogen based hormonal contraceptives, must agree to use alternate contraceptive measures for the estrogen-based contraceptive. They must still fulfill the requirement to use an acceptable double method of birth control (one of which must be a barrier method).
• Male subjects must have agreed not to donate sperm from the first dose through at least 6 months after the last dose of study drugs.
• QTcF interval: S 450 ms at Screening and prior to dosing on Day 1.
• Documented clinical history compatible with chronic hepatitis C, including any one of the following:
• Anti- HCV antibody positive at least 6 months prior to Screening or dosing, OR
• HCV RNA present in plasma by a sensitive and specific assay at least 6 months prior to Screening or dosing, OR
• HCV genotype at least 6 months prior to Screening or dosing, OR
• Histologic evidence of chronic hepatitis C infection.
• Plasma HCV RNA positive at Screening with minimal viral load according to genotype:
• GTI a (Q80K negative), I b and 6 HCV RNA 2::5 log10 IU/mL
• GT4 HCV RNA 2:: 4 log10 IU/mL
• Documented absence of cirrhosis within 36 months of Screening or dosing (histology or non-invasive equivalent, according to local standard of care).
• Subject is, in the opinion of the investigator, willing and able to comply with the protocol and all other study requirements.
• Subject has provided written informed consent to participate in the study.
Read the full story at http://www.prweb.com/releases/2014/01/prweb11509209.htm
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