Hepatitis CPhase 1NCT00128271
Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection
A Phase 1 study testing Bavituximab in people with Hepatitis C, run by Peregrine Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of bavituximab when administered via a vein as a single infusion and to examine how bavituximab behaves in the body and how it affects the amount of hepatitis C virus in individuals with chronic infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Bavituximab
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2006
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Chronic hepatitis C infection based on history and detectable serum HCV RNA
- Documented failure to respond to or relapse after treatment with pegylated interferon and ribavirin combination therapy
- Adequate hematologic function (absolute neutrophil count [ANC] greater than or equal to 1,500 cells/uL, hemoglobin [Hgb] greater than or equal to 12 g/dL in females and greater than or equal to 13 g/dL in males, platelet count greater than or equal to 100,000/uL and less than or equal to 500,000/uL)
- Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min)
- Normal coagulation profile (PT/INR and aPTT within institutional normal limits)
- D-dimer within institutional limits
- Female patients of childbearing potential must have a negative serum pregnancy test at prestudy and all patients of reproductive potential must be willing to use an approved form of barrier method contraception
Who cannot join
- Prior exposure to any chimeric antibody
- Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease
- Decompensated clinical liver disease or cirrhosis
- Any evidence of clinically significant bleeding
- Known history of bleeding diathesis or coagulopathy
- Any history of thromboembolic events including central venous catheter-related thrombosis
Show all 21Show fewer
- Any evidence or history of a hypercoagulable state (eg, elevated d-dimer or shortened aPTT)
- Concurrent therapy with oral or parenteral anticoagulants
- Concurrent hormone therapy (ie, estrogen contraceptives, hormone replacement, anti-estrogen)
- Antiviral therapy within 90 days of day 0
- Investigational therapy within 4 weeks of day 0
- Major surgery within 4 weeks of day 0
- Uncontrolled intercurrent disease
- Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
- A history of any condition requiring treatment (past or current) with coumarin-type agents
- Cardiac arrhythmia requiring medical therapy
- Serious non-healing wound
- Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
- A disease or concurrent therapy known to cause significant alteration in immunologic function
- Known HIV or active hepatitis B virus (HBV) infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients Chronically Infected With Hepatitis C Virus (HCV) Who Are Non-Responders or Relapsers After Treatment With Pegylated Interferon Plus Ribavirin
The purpose of this study is to determine the safety and tolerability of bavituximab when administered via a vein as a single infusion and to examine how bavituximab behaves in the body and how it affects the amount of hepatitis C virus in individuals with chronic infection.
Read the detailed description
Hepatitis C virus (HCV) infection is a world wide public health concern and is the most common chronic bloodborne infection in the United States and the leading indication for liver transplantation. Laboratory and animal studies have demonstrated that bavituximab binds viruses and virally infected cells and prolongs survival in infected animals. This study will examine the safety and tolerability of bavituximab when administered to patients with chronic HCV infection who do not respond to or relapse after treatment with pegylated interferon plus ribavirin combination therapy. Groups of patients will be treated with escalating doses and followed for 12 weeks.
- Conditions
- Hepatitis C
- Being tested
- Bavituximab
- Keywords
- HCV, monoclonal antibody, phase 1
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BavituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
laboratory evaluations
human anti-chimeric antibody
pharmacokinetic analysis
viral kinetic analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eliot W Godofsky, MD, FACP, Principal investigator, Bach & Godofsky, MD, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128271
- Sponsor's protocol ID
- PPHM 0501
- Status last verified
- Aug 2006
- First submitted
- 8 Aug 2005
- Last updated
- 7 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients Chronically Infected With Hepatitis C Virus (HCV) Who Are Non-Responders or Relapsers After Treatment With Pegylated Interferon Plus Ribavirin
- ClinicalTrials.gov ID
- NCT00128271
- Acronym / sponsor ID
- PPHM 0501
- Conditions
- Hepatitis C
- Keywords
- HCV, monoclonal antibody, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2006 (actual)
- First posted
- 9 Aug 2005 (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 determine the safety and tolerability of bavituximab when administered via a vein as a single infusion and to examine how bavituximab behaves in the body and how it affects the amount of hepatitis C virus in individuals with chronic infection.
Detailed description
Hepatitis C virus (HCV) infection is a world wide public health concern and is the most common chronic bloodborne infection in the United States and the leading indication for liver transplantation. Laboratory and animal studies have demonstrated that bavituximab binds viruses and virally infected cells and prolongs survival in infected animals. This study will examine the safety and tolerability of bavituximab when administered to patients with chronic HCV infection who do not respond to or relapse after treatment with pegylated interferon plus ribavirin combination therapy. Groups of patients will be treated with escalating doses and followed for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Chronic hepatitis C infection based on history and detectable serum HCV RNA
- Documented failure to respond to or relapse after treatment with pegylated interferon and ribavirin combination therapy
- Adequate hematologic function (absolute neutrophil count [ANC] greater than or equal to 1,500 cells/uL, hemoglobin [Hgb] greater than or equal to 12 g/dL in females and greater than or equal to 13 g/dL in males, platelet count greater than or equal to 100,000/uL and less than or equal to 500,000/uL)
- Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min)
Key exclusion criteria (21 listed)
- Prior exposure to any chimeric antibody
- Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease
- Decompensated clinical liver disease or cirrhosis
- Any evidence of clinically significant bleeding
- Known history of bleeding diathesis or coagulopathy
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 |
|---|---|---|
| Bavituximab | Drug | – |
Primary outcome
adverse events
laboratory evaluations
human anti-chimeric antibody
pharmacokinetic analysis
viral kinetic analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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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.
Eliot W Godofsky, MD, FACP principal investigator
Bach & Godofsky, MD, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bavituximab in people with Hepatitis C, run by Peregrine Pharmaceuticals at 1 site 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 8 inclusion and 21 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: finished, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adverse events. The study lists 5 primary outcomes in all. 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 7 May 2008.