Hepatitis CPhase 1NCT00343525
Repeat-Dose Study of Bavituximab in Patients With Chronic Hepatitis C
A Phase 1 study testing bavituximab in people with Hepatitis C, run by Peregrine Pharmaceuticals at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of bavituximab when administered via an arm vein as multiple infusions and to examine how bavituximab behaves in the body and how it effects the amount of hepatitis C virus and immune modulators 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
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to Jan 2007
- 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 including treatment naïve subjects as well as subjects who are partial responders and/or relapsers to prior therapy(ies)
- All genotypes of HCV acceptable
- Complete Blood Counts within normal limits
- Normal renal function (serum creatinine within normal limits)
- Normal coagulation profile (PT/INR and aPTT within normal limits)
- Patients of reproductive potential must agree to use an approved form of barrier contraception. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
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, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
- Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
- Any history of thromboembolic events [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)] including central venous catheter-related thrombosis within the past 12 months
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- Concurrent therapy with oral or parenteral anticoagulants
- Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
- Antiviral therapy within 4 weeks of day 0
- Investigational therapy within 4 weeks of day 0
- Major surgery within 4 weeks of day 0
- Pregnant or nursing women
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid 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 (including wound healing by secondary intention, ulcer, or bone fracture)
- Requirement for chronic daily treatment with NSAIDs, antiplatelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
- Cancer, autoimmune disease or any disease or concurrent therapy known to cause significant alteration in immunologic function
- Known chronic infection with HIV or HBV
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alamo Medical Research
San Antonio, Texas, 78215
University Hepatitis Center at Bach & Godofsky MD PA
Sarasota, Florida, 34243
About this study
Official title: A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients With Chronic Hepatitis C
The purpose of this study is to determine the safety and tolerability of bavituximab when administered via an arm vein as multiple infusions and to examine how bavituximab behaves in the body and how it effects the amount of hepatitis C virus and immune modulators 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 lethally infected animals. This study will examine the safety and tolerability of bavituximab when administered as multiple infusions to patients with chronic HCV infection. Groups of patients will be treated with escalating doses of bavituximab twice weekly for 2 weeks 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
cytokine analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2007
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Lawitz, MD, Principal investigator, Alamo Medical ResearchEliot W Godofsky, MD, Principal investigator, University Hepatitis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343525
- Sponsor's protocol ID
- PPHM 0601
- Status last verified
- Apr 2008
- First submitted
- 21 Jun 2006
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- 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 Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00343525
- Acronym / sponsor ID
- PPHM 0601
- Conditions
- Hepatitis C
- Keywords
- HCV, monoclonal antibody, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 23 Jun 2006 (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 an arm vein as multiple infusions and to examine how bavituximab behaves in the body and how it effects the amount of hepatitis C virus and immune modulators 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 lethally infected animals. This study will examine the safety and tolerability of bavituximab when administered as multiple infusions to patients with chronic HCV infection. Groups of patients will be treated with escalating doses of bavituximab twice weekly for 2 weeks 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 (7 listed)
- At least 18 years of age
- Chronic Hepatitis C infection based on history and detectable serum HCV RNA including treatment naïve subjects as well as subjects who are partial responders and/or relapsers to prior therapy(ies)
- All genotypes of HCV acceptable
- Complete Blood Counts within normal limits
- Normal renal function (serum creatinine within normal limits)
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, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
- Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
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
cytokine 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.
Eric Lawitz, MD principal investigator
Alamo Medical Research
Eliot W Godofsky, MD principal investigator
University Hepatitis Center
2 sites 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 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 7 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 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. 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 6 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.