Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C Virus
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Intravenous Doses of ANZ-521 in Hepatitis C Patients|
- Subject incidence of AEs, clinically relevant changes in lab values, ECGs, and vital signs [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
- Plasma HCV RNA titers relative to baseline [ Time Frame: 84 days ] [ Designated as safety issue: No ]
- Serum transaminase levels relative to baseline [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
- Innate and adaptive immune responses induced by ANZ-521 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
- Blood, stool, and urine cultures of ANZ-521 [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: ANZ-521||
3x10^7 cfu or 3x10^8 cfu ANZ-521 in 250 mL, IV over 2 hours, every 28 days for up to 3 doses.
|Placebo Comparator: Placebo||
250 mL normal saline, IV over 2 hours, every 28 days for up to 3 doses.
This Phase 1/2 Randomized, Placebo Controlled, Double-Blind clinical trial will evaluate the safety, tolerability, and pharmacodynamics of ANZ-521, an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. ANZ-521 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. ANZ-521 has also been genetically modified with recombinant DNA to encode consensus sequence antigens called NS5B polymerase and NS3 proteinase that correspond to viral proteins found on the virus causing Hepatitis C. It is hoped that ANZ-521 will stimulate an immune response to the Hepatitis C virus (HCV) in the liver, thereby demonstrating an effective therapy for individuals with chronic HCV infection.
The purpose of this first clinical trial with ANZ-521 is to identify an appropriate dose of the investigational agent for later clinical studies and to explore safety when given to consenting adults with HCV. Immunological response to ANZ-521 in study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria. The first part of the study (Part A) will enroll subjects who have received prior treatment with standard of care therapy for HCV. The second part of the study (Part B) will enroll subjects who have not previously received standard of care therapy for HCV or were intolerant to standard of care. Qualifying study patients will be assigned to receive one of at least 2 dose levels of ANZ-521 or placebo. Each patient may receive up to 3 intravenous administrations (28 days apart) of ANZ-521 or placebo at their assigned dose level.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800007
|United States, California|
|Advanced Clinical Research Institute|
|Anaheim, California, United States, 92801|
|United States, Texas|
|Alamo Medical Research|
|San Antonio, Texas, United States, 78215|