Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C Virus

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anza Therapeutics, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.