Status:
TERMINATED
Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C Virus
Lead Sponsor:
Anza Therapeutics, Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, immunogenicity, and antiviral effects of multiple intravenous doses of ANZ-521 in patients with chronic Hepatitis C virus.
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- Chronic liver disease consistent with chronic hepatitis C infection, genotype 1, for at least 6 months
- For Part A only: patients who have had a full course of interferon and ribavirin as defined by the NIH Consensus Statement for the Management of Hepatitis C: 2002 (Management of hepatitis C: 2002, 2002) and have a detectable viral titer at Screening.
- For Part B only: patients who are HCV treatment-naïve with known contraindications (i.e., history of depression) to interferon and ribavirin combination therapy; patients who have started on interferon and ribavirin but stopped therapy early due to intolerance; patients who have not received interferon and ribavirin and have refused therapy
- Plasma HCV RNA viral titer of ≥ 2 logs above the assay cutoff measured at Screening.
- Females must be of non-child bearing potential \[i.e., 1 year post menopausal or documented as being surgically sterile\].
- Men must agree to use an acceptable form of birth control through the study and for 28 days after final dose of ANZ-521.
- Liver biopsy within the last 3 years with an Ishak Score \<3 of FibroSURE test score \<0.59.
- Compensated liver disease (Child-Pugh class A) with the adequate organ function as defined by study-specific laboratory tests.
- Signed Informed Consent and willing and able to comply with all study procedures.
Exclusion
- Patients who are null responders to interferon-based therapy as defined by a less than 1-log decrease in viral titer from baseline during treatment.
- Treatment with anti-HCV therapy within one month prior to study.
- History of infection with Listeria.
- History of having received an experimental HCV vaccine (therapeutic or preventive).
- Known allergy to both penicillin and sulfa drugs, or component of the study drug product (e.g., glycerol).
- Current or prior history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical condition.
- Artificial (prosthetic) joint or other artificial implant or devices that cannot be easily removed.
- History of malignancy of any type, other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years.
- Taking certain medications such as more than 2 g of acetaminophen per day, systemic antibiotics within 14 days of study entry, another investigational product within 28 days of study entry.
- Recent hospitalization or planned surgery requiring general anesthesia or sedation.
- Drug screen positive for cocaine.
- Positive for HIV or Hepatitis B antibodies.
- Blood donation of more than 450 mL within 8 weeks of study entry.
- Other condition that might affect the subject's ability to give informed consent or comply with study requirements.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00800007
Start Date
November 1 2008
End Date
February 1 2009
Last Update
February 20 2009
Active Locations (2)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Alamo Medical Research
San Antonio, Texas, United States, 78215