ORLANDO, FL, January 24, 2014 /24-7PressRelease/ -- *To see if you qualify for this Hepatitis C Clinical Trial in Florida, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.---
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.
Avail Clinical Research conducts a variety of Clinical Trials in Florida. For more information about participating in a Hepatitis C Clinical Study, please visit our website or contact us directly at (386) 785-2404.
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