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

NCT00800007 | Terminated Phase 1 DMC

• 1 other identifier: ANZ-521-101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C, HCV, ANZ-521, Listeria

Outcome Measures

Primary Outcomes (1)

• Subject incidence of AEs, clinically relevant changes in lab values, ECGs, and vital signs

  84 days

Secondary Outcomes (4)

• Plasma HCV RNA titers relative to baseline

  84 days

• Serum transaminase levels relative to baseline

  84 days

• Innate and adaptive immune responses induced by ANZ-521

  84 days

• Blood, stool, and urine cultures of ANZ-521

  84 days

Study Arms (2)

ANZ-521

ACTIVE COMPARATOR

Drug: ANZ-521

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ANZ-521 DRUG

3x10\^7 cfu or 3x10\^8 cfu ANZ-521 in 250 mL, IV over 2 hours, every 28 days for up to 3 doses.

ANZ-521

Placebo DRUG

250 mL normal saline, IV over 2 hours, every 28 days for up to 3 doses.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anza Therapeutics, Inc.: lead

Study Sites (2)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

US (2)