Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults

Hepatitis C Clinical Trial

Official title: A Randomized, Double-Blind, Phase 1b Study to Assess the Safety and Activity of the HCV Entry Inhibitor ITX 5061 in Treatment-Naive HCV Mono-Infected Adults

Status Completed

Clinical Trial Summary

Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood.

Clinical Trial Description

HCV is a serious health concern and can lead to cirrhosis, liver cancer, and liver failure. Currently, HCV is treated with pegylated interferon and ribavirin, but these medications are not always effective and may have harmful side effects. ITX 5061 is a new medication that has been developed to treat HCV. This study will take place in three parts-Parts A, B, and C. Each part of the study will enroll participants for a different period of time, and within each part of the study, participants will receive varying amounts of ITX 5061. If ITX 5061 is found to be unsafe in any part of the study, the subsequent parts of the study will not occur. The purpose of this study is to evaluate the safety of different doses of ITX 5061 and determine the amount of time that is needed for ITX 5061 to safely lower the amount of HCV in the blood. This study will enroll people with HCV who are HIV-uninfected. Participants will enroll in one of three parts of the study. They will be randomly assigned to receive ITX 5061 or placebo once a day for 3 days in Part A, for 14 days in Part B, or for 28 days in Part C. Within Parts A, B, and C, participants will receive either 150 mg, 75, mg, or 25 mg of ITX 5061. At a baseline study visit, participants will have a physical exam and blood and urine collection. All participants will receive their assigned medication at this visit. Participants in Part A will return for study visits on the 2 days after the baseline visit. During these study visits, participants will undergo a physical exam and will have blood collected several times over an 8-hour period. Participants in Part B of the study will attend study visits 1, 2, 3, 7, 10, and 13 days after the baseline visit. Participants in Part C of the study will attend study visits 1, 2, 3, 7, 10, 14, 21, and 27 days after the baseline visit. Participants in Parts B and C will undergo similar study procedures as participants in Part A. Throughout the study, participants will record their medication usage in a diary. All participants will attend a study visit the day after they receive their last medication dose. In addition, participants in Part A will attend study visits 9 and 16 days after the baseline visit, participants in Part B will attend study visits 20 and 27 days after the baseline visit, and participants in Part C will attend study visits 34 and 41 days after the baseline visit. At each of these follow-up visits, participants will have a physical exam and a blood and urine collection. ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

• NCT number: NCT01165359
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: September 2010
• Completion date: March 2012