The primary objectives of this study are to evaluate the 12-week safety, antiviral activity and tolerability of this new Hep C drug when given in combination with PEG and RIBA as measured by extended rapid virologic response.
DeLand, Florida (PRWEB) September 17, 2012
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.
In the United States, the prevalence of HCV infection between the years 1999 and 2002 was 1.6%, with approximately 4.1 million persons positive for the antibody to HCV. Of these, 80% were estimated to be viremic. There are approximately 9 million people chronically infected with HCV in Europe. Hepatitis C virus is the primary cause of death from liver disease and the leading indication for liver transplantation in the United States. It's important to learn about the symptoms of Hep C so you know what to look for.
Hepatitis C virus-related mortality (death from liver failure or hepatocellular carcinoma) is expected to continue to increase over the next 2 decades. The Hepatitis C virus can be classified into at least 6 major genotypes (genotypes 1 to 6). Genotype 1 (subtypes 1a and 1b) is the most common in the United States and Europe, followed by genotypes 2 and 3. However, less common genotypes (genotypes 4 to 6) are beginning to be observed more frequently because of the growing cultural diversity in Western countries.
**Avail Clinical Research is now enrolling for this Hepatitis C Clinical Trial in Central Florida. 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-Naïve 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-naïve subjects with chronic genotype 1 HCV infection.
Subjects will be randomly allocated on a 2:2:1 basis to 2 dose levels of the new drug or telaprevir and will be stratified by interleukin 28B (IL28B) rs12979860 status, HCV viral genotype (i.e., 1a vs 1b), and baseline HCV viral load. Telaprevir, PEG, and RIBA will be administered in an open-label manner while the 2 dose levels of this new Hep C drug will be administered in a double-blind manner.
In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of the new Hep C treatment. After completion of 12 weeks of the new drug along with PEG and RIBA, subjects will continue with 12 or 36 additional weeks of PEG and RIBA treatment depending on virological status.
Subjects randomly assigned to the telaprevir arm will receive therapy with PEG, RIBA, and telaprevir according to the telaprevir label. The primary objective of the study is to evaluate the safety and antiviral activity of the new drug when given in combination with PEG and RIBA.
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 when given in combination with PEG and RIBA as measured by extended rapid virologic response (eRVR, defined as undetectable plasma HCV RNA at Weeks 4 and 12)
INCLUSION CRITERIA
Specific information regarding warnings, precautions, contraindications, AEs, and other pertinent information on the new Hep C treatment that may impact subject eligibility is provided in the current IB for the new drug. Specific information regarding warnings, contraindications, and other pertinent information on other study treatments (PEG, RIBA, ± telaprevir) can be found in the respective product labels.
Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability, or subject safety. Therefore, adherence to the criteria, as specified in the protocol, is essential.
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 naïve 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)
- 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
- Childbearing potential and has a negative urine or serum pregnancy test at Screening and within the 24-hour period prior to the first dose of study medication and completely abstains from intercourse for 2 weeks before exposure to the study medication, throughout the clinical study, and for 24 weeks after completion or premature discontinuation from this study or uses 2 of the following acceptable methods of contraception throughout the clinical study and for 24 weeks after completion or premature discontinuation from this study:*
- 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
*Note: For women of childbearing potential in the new Hep C treatment arms who continue with SoC therapy following discontinuation from the study due to lack of efficacy, contraception must also be utilized throughout the treatment and for a 24-week follow-up period after completion of treatment to avoid pregnancy. Routine pregnancy testing must also be performed. The investigator is responsible for ensuring that appropriate forms of contraception are utilized along with pregnancy testing in accordance with the approved product labels for the anti-HCV agents utilized in any post-study SoC regimen.
*Note: Per the telaprevir label, hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for up to 2 weeks following cessation of telaprevir. During this time, female subjects of childbearing potential should use 2 effective nonhormonal methods of contraception. Examples may include barrier methods or intrauterine devices. Two weeks after completion of telaprevir treatment, hormonal contraceptives are again appropriate as 1 of the 2 required effective methods of birth control; however, specific prescribing information recommendations should be followed for the contraceptives.
11. Is otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Avail Clinical Research 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.
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