Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C Virus
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|ClinicalTrials.gov Identifier: NCT00800007|
Recruitment Status : Terminated
First Posted : December 1, 2008
Last Update Posted : February 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: ANZ-521 Drug: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
|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.
- Subject incidence of AEs, clinically relevant changes in lab values, ECGs, and vital signs [ Time Frame: 84 days ]
- Plasma HCV RNA titers relative to baseline [ Time Frame: 84 days ]
- Serum transaminase levels relative to baseline [ Time Frame: 84 days ]
- Innate and adaptive immune responses induced by ANZ-521 [ Time Frame: 84 days ]
- Blood, stool, and urine cultures of ANZ-521 [ Time Frame: 84 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|