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New Phase 2 Paid Hepatitis C Clinical Trial Now Enrolling at Avail Clinical Research in Central Florida; Accepting Male & Female Participants Age 18-70.

Orlando, FL, September 19, 2012 --(PR.com)-- The Hepatitis C Virus (HCV) is a major public health problem globally and a leading cause of chronic liver disease. The World Health Organization estimates that 180 million people are infected with HCV worldwide.

**Avail Clinical Research is now enrolling for this Hepatitis C Clinical Trial in Central Florida (http://www.availclinical.com/trial/2521/). To get started, visit http://www.availclinical.com or call us directly at (386) 310-1334.

Study Title

A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of this new Hep C drug with Pegylated Interferon and Ribavirin in Treatment-Naive Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection.

Description

The new Hep C drug is a novel hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of the new drug at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naive subjects with chronic genotype 1 HCV infection.

Objectives

The primary objectives of this study are:

1. To evaluate the 12-week safety and tolerability of 40 and 60 mg of the new Hep C drug when given in combination with PEG and RIBA

2. To evaluate 12-week antiviral activity of 40 and 60 mg of the new Hep C drug

Inclusion Criteria

Subjects eligible for enrollment in the study must meet all of the following criteria:

1. Is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

2. Is male or female aged 18 to 70 years, inclusive, at Screening.

3. Has chronic genotype 1 or genotype 4 (as assessed by VERSANT HCV Genotype assay 2.0 (LiPA); Siemens Healthcare Diagnostics, Deerfield, Illinois) HCV infection documented by at least 1 measurement of serum HCV RNA ≥100,000 IU/mL measured during Screening by the COBAS High Pure/COBAS

TaqMan HCV Test v2.0 (Roche Molecular Diagnostics, Pleasanton, California) and at least one of the following:

A positive anti-HCV antibody, HCV RNA, or HCV genotype test at least 6 months prior to Baseline (Day 1) together with positive HCV RNA and anti-HCV antibody tests at the time of Screening

A positive HCV RNA test and anti-HCV antibody test at the time of Screening together with either a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).

4. Is naive to all HCV antiviral treatment(s), including, but not limited to, immunomodulatory and nucleoside/nucleotide treatments for chronic HCV infection.

5. Agrees to IL28B genotyping.

6. Is a subject, who, in the opinion of the investigator, is an appropriate candidate for PEG/RIBA/protease inhibitor combination therapy for genotype 1 subjects and PEG/RIBA combination therapy for genotype 4 subjects.

7. Has a body mass index >18 kg/m2 but not exceeding 36 kg/m2.

8. Has a liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of noncirrhotic as judged by a local pathologist (defined as Knodell ≤3, Metavir ≤2, Ishak ≤4, or Batts and Ludwig ≤2). Both incomplete and transition to cirrhosis (e.g., Metavir score 3) are considered as cirrhosis. If no recent (<36 months) liver biopsy is available, a study-qualifying biopsy must be performed prior to Baseline (Day 1).

9. For all fertile males and females, must use 2 forms of effective contraception (as defined in inclusion criterion #10) between them during treatment and during the 24 weeks after treatment ends.

10. For females, 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

Is postmenopausal (demonstrate total cessation of menses for greater than

1 year) (see also: Why Baby Boomers should be tested for Hep C)

Childbearing potential and has a negative urine or serum pregnancy test

Any intrauterine device with a documented failure rate of <1% per year

Double-barrier contraception (condom, diaphragm, or cervical cap used with spermicidal jelly)

Male partner who is sterile prior to the female subject's study entry and is the sole sexual partner for that female

Any other contraceptive method with a documented failure rate of <1% per year

11. Is otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening.

Avail Clinical Research (http://www.availclinical.com/) is a privately owned research facility near Orlando, FL. Our entire staff prides itself on providing rapid study start-up, expeditious, precise project management and timely protocol completion.

Contact Information:

Avail Clinical Research

Kimberly Mantuano

(386) 310-1334

Contact via Email

http://www.availclinical.com/
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Date:Sep 19, 2012
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