Chronic Hepatitis CPhase 1/2NCT00800007
Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C Virus
A Phase 1/2 study testing ANZ-521 in people with Chronic Hepatitis C, run by Anza Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- ANZ-521
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Feb 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Alamo Medical Research
San Antonio, Texas, 78215
About this study
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
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.
Read the 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 (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.
- Conditions
- Chronic Hepatitis C
- Being tested
- ANZ-521, Placebo
- Keywords
- Hepatitis C, HCV, ANZ-521, Listeria
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANZ-521Drug
3x10^7 cfu or 3x10^8 cfu ANZ-521 in 250 mL, IV over 2 hours, every 28 days for up to 3 doses.
PlaceboDrug
250 mL normal saline, IV over 2 hours, every 28 days for up to 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| ANZ-521 | Active comparator | Not described Receives: Drug: ANZ-521 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of AEs, clinically relevant changes in lab values, ECGs, and vital signs
Measured: 84 days
Secondary outcomes (4)
Plasma HCV RNA titers relative to baseline
Measured: 84 days
Serum transaminase levels relative to baseline
Measured: 84 days
Innate and adaptive immune responses induced by ANZ-521
Measured: 84 days
Blood, stool, and urine cultures of ANZ-521
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anza Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800007
- Sponsor's protocol ID
- ANZ-521-101
- Status last verified
- Feb 2009
- First submitted
- 26 Nov 2008
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00800007
- Acronym / sponsor ID
- ANZ-521-101
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, HCV, ANZ-521, Listeria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Anza Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANZ-521 | Active comparator | Drug: ANZ-521 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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].
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANZ-5213x10^7 cfu or 3x10^8 cfu ANZ-521 in 250 mL, IV over 2 hours, every 28 days for up to 3 doses. | Drug | ANZ-521 |
| Placebo250 mL normal saline, IV over 2 hours, every 28 days for up to 3 doses. | Drug | Placebo |
Primary outcome
Subject incidence of AEs, clinically relevant changes in lab values, ECGs, and vital signs
Time frame: 84 days
4 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ANZ-521 in people with Chronic Hepatitis C, run by Anza Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject incidence of AEs, clinically relevant changes in lab values, ECGs, and vital signs (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.