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Dose-Ranging Study of PSI-7977 in Combination With SOC in Treatment Naïve GT 1 HCV Patients

2014-07-23 21:11:01 | BioPortfolio

Summary

This Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study will Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Oral Administration of PSI-7977 in Combination with Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients with Chronic HCV Infection Genotype 1. Approximately 60 treatment-naive GT-1 HCV infected patients will be enrolled in three parallel cohorts. Each cohort will receive PSI-7977, ranging from 100mg to 400mg, or matching placebo tablets, on Days 0-28. Patients will also receive treatment with SOC (PEG-IFN and RBV) starting on Day 0 of this trial, and continuing for 48 weeks. Eligible patients will be randomized to one of the 3 active cohorts based upon stratification for IL-28b status; each cohort will consist of twenty (20) subjects, with 16 subjects assigned to active PSI-7977 and 4 subjects assigned to matching placebo in a 4:1 randomization.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Hepatitis C

Intervention

PSI-7977

Location

Quest Clinical Research
San Francisco
California
United States
94115

Status

Active, not recruiting

Source

Pharmasset

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:01-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

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