Hepatitis C VirusPhase 1NCT00503347
Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
A Phase 1 study testing bavituximab in people with Hepatitis C Virus and Hiv Infections, run by Peregrine Pharmaceuticals at 6 sites in United States.
Trial summary
This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus, Hiv Infections
- What is being tested?
- bavituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2007to Jun 2011
- 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
- Written informed consent has been obtained
- Adults 18 years of age or older
- HIV infection documented by detectable HIV RNA PCR
- Absolute CD4+ > 300 cells/mm3
- Chronic hepatitis C infection based on history and detectable serum HCV RNA
- Serum alanine aminotransferase (ALT) above normal limits and/or historical biopsy consistent with hepatitis C
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- Complete blood counts within normal limits
- Normal renal function (serum creatinine within normal limits)
- PT/INR and aPTT within normal limits
- All patients of reproductive potential must agree to use an approved form of barrier contraception or agree not to become pregnant while taking study medications and for 30 days after study completion. 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
- HCV or HIV antiviral therapy within 4 weeks of Day 0
- 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)
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- Any history of thromboembolic events [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)]. A history of including central venous catheter-related thrombosis is acceptable if there is documentation of resolution at least 12 months prior to enrollment.
- Concurrent therapy with oral or parenteral anticoagulants
- Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
- 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. Corticosteroids administered as pre-treatment, or to treat an adverse event, are allowed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Johns Hopkins University, Center for Viral Hepatitis
Baltimore, Maryland, 21287
Southwest Infectious Disease Associates
Dallas, Texas, 75204
Impact Clinical Research
Los Angeles, California, 90036
Saint Michael's Medical Center
Newark, New Jersey, 07102
Orange Coast Medical Center
Newport Beach, California, 92663
About this study
Official title: A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.
Read the detailed description
OBJECTIVES:
- To determine the safety and tolerability of bavituximab administered as multiple intravenous (IV) infusions to patients co-infected with HCV and HIV
- To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV
- To define the maximum tolerated dose (MTD) and/or maximum effective dose (MED) of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV
- Conditions
- Hepatitis C Virus, Hiv Infections
- Being tested
- bavituximab
- Keywords
- coinfection with chronic hepatitis C virus and HIV, Treatment Naive
- Medical subject headings
- Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bavituximabDrug
The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.3 mg/kg Receives: Drug: bavituximab |
| 2 | Experimental | 1 mg/kg Receives: Drug: bavituximab |
| 3 | Experimental | 3 mg/kg Receives: Drug: bavituximab |
| 4 | Experimental | 6 mg/kg Receives: Drug: bavituximab |
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
Secondary outcomes (1)
Blood levels of HCV RNA and HIV RNA (PCR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jihad Slim, MD, Principal investigator, Saint Michael's Medical CenterMark S. Sulkowski, MD, Principal investigator, Johns Hopkins University, Center for Viral HepatitisJorge Rodriguez, MD, Principal investigator, Orange Coast Medical CenterNicholaos C. Bellos, MD, Principal investigator, Southwest Infectious Disease AssociatesLydie Hazan, MD, Principal investigator, Impact Clinical TrialsMelaine Thompson, MD, Principal investigator, AIDS Research Consortium of Atlanta (ARCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503347
- Sponsor's protocol ID
- PPHM 0603
- Status last verified
- Jun 2011
- First submitted
- 16 Jul 2007
- Last updated
- 9 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. 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 Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT00503347
- Acronym / sponsor ID
- PPHM 0603
- Conditions
- Hepatitis C Virus, Hiv Infections
- Keywords
- coinfection with chronic hepatitis C virus and HIV, Treatment Naive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Jul 2007 (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.
This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.
Detailed description
OBJECTIVES:
- To determine the safety and tolerability of bavituximab administered as multiple intravenous (IV) infusions to patients co-infected with HCV and HIV
- To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV
- To define the maximum tolerated dose (MTD) and/or maximum effective dose (MED) of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bavituximab0.3 mg/kg |
| 2 | Experimental | Drug: bavituximab1 mg/kg |
| 3 | Experimental | Drug: bavituximab3 mg/kg |
| 4 | Experimental | Drug: bavituximab6 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent has been obtained
- Adults 18 years of age or older
- HIV infection documented by detectable HIV RNA PCR
- Absolute CD4+ > 300 cells/mm3
- Chronic hepatitis C infection based on history and detectable serum HCV RNA
Key exclusion criteria (20 listed)
- HCV or HIV antiviral therapy within 4 weeks of Day 0
- 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
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 |
|---|---|---|
| bavituximabThe study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab. | Drug | 1, 2, 3, 4 |
Primary outcome
• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis
1 secondary outcome
Blood levels of HCV RNA and HIV RNA (PCR)
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 9 Jun 2011.
- Click here for more information about bavituximab and this study: A safety and pharmacokinetic study of bavituximab in patients co-infected with chronic hepatitis C virus and human immunodeficiency virus.Link provided by the sponsor.
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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.
Jihad Slim, MD principal investigator
Saint Michael's Medical Center
Mark S. Sulkowski, MD principal investigator
Johns Hopkins University, Center for Viral Hepatitis
Jorge Rodriguez, MD principal investigator
Orange Coast Medical Center
6 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 Virus and Hiv Infections, run by Peregrine Pharmaceuticals at 6 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 10 inclusion and 20 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis. 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 9 Jun 2011.