Avail is conducting a 12-week, Phase 2, Randomized Study to Evaluate the Safety and Efficacy of a new drug in Subjects with Chronic Hepatitis C Infection.
DeLand, Florida (PRWEB) June 03, 2013
*To see if you qualify for this Hepatitis C Clinical Trial, visit Avail Clinical Research on the web or contact us directly at (386) 785-2404.
BACKGROUND
The Hepatitis C virus (HCV) infection is a global public health problem. The global prevalence of hepatitis C infection is estimated to average 3% resulting in approximately 170 million HCV-infected persons worldwide. Most of those infected develop persistent, chronic infection. An estimated 20-50% of patients with chronic HCV infection are at risk for developing such long-term complications as cirrhosis and hepatocellular carcinoma (HCC).
PRIMARY OBJECTIVES
The primary objectives of this Hep C Clinical Study are to evaluate the:
Safety and tolerability of a new Hep C drug and simeprevir when given in combination with RBV for up to 12 weeks.
Efficacy of a new Hep C drug and simeprevir when given in combination with RBV for up to 12 weeks.
SECONDARY OBJECTIVES
The secondary objectives are to evaluate the:
1. Pharmacokinetics (PK) of a new Hepatitic C drug and simeprevir when given in combination with RBV.
2. PK/Pharmacodynamics (PK/PD) of a new Hepatitic C drug and simeprevir when given in combination with RBV.
3. Emergence of resistance mutations over 12-weeks of combination treatment of a new Hepatitic C drug, simeprevir and RBV and in the post-treatment follow-up period.
INCLUSION CRITERIA
1. 18 (or the legal age of consent per local regulations, if greater than 18 years) to 65 years of age, inclusive.
2. 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.
3. All female subjects must have a negative serum beta-human chorionic gonadotropin (β-HCG) at Screening and a negative urine pregnancy test prior to the first dose of study medication on Day 1.
4. 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.
5. 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.
6. QTcF interval ≤ _450 ms at Screening and prior to dosing on Day 1.
7. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
a) anti- HCV antibody positive at least 6 months prior to Screening or dosing, OR
b) HCV RNA present in plasma by a sensitive and specific assay at least 6 months prior to Screening or dosing, OR
c) HCV genotype at least 6 months prior to Screening or dosing, OR
d) histologic evidence of chronic hepatitis C infection.
8. Must not have received prior antiviral treatment for HCV infection.
9. Plasma HCV RNA positive at Screening with minimal viral load according to genotype:
a) Genotype 1b HCV RNA ≥5 log10 IU/mL
b) Genotype 4 HCV RNA ≥ _4 log10 IU/mL
10. HCV genotype 1b or 4 by HCV genotyping performed at Screening (Note: mixed subtypes are not acceptable).
11. Documented absence of cirrhosis within 36 months of Screening or dosing (histology or non-invasive equivalent, according to local standard of care).
12. Subject is, in the opinion of the investigator, willing and able to comply with the protocol and all other study requirements.
13. Subject has provided written informed consent to participate in the study.
- Receive medical care at No Cost
- Health Insurance is not required
- Receive Compensation for time & travel
- Help Advance medical research
*Achieve Clinical Research conducts Clinical Research Trials in Florida. For more information about participating in a Hep C Clinical Study, please visit our website or contact us directly at (386) 785-2404.
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