West Nile FeverPhase 1NCT00091845
An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) Disease
A Phase 1 study testing AVI-4020 Injection in people with West Nile Fever, run by Sarepta Therapeutics, Inc..
Trial summary
Although the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive disease, is rare, it can result in permanent disabilities and occasionally death. For patients who get this serious form of WNV disease, there are no approved specific treatment options. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- West Nile Fever
- What is being tested?
- AVI-4020 Injection
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Nov 2004
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a positive serum or CSF ELISA MAC-IgM test indicating active/recent WNV infection, or the Subject resides in or has traveled to geographic areas with at least one of the following characteristics within the last seven days:
- Documented evidence of WNV infected mosquitoes or sentinel animals within the last 30 days
- Documented evidence of WNV infected dead animals within the last 30 days
- Documented human cases of WNV infection/disease within the last two weeks
- Subject is between >18 and <75 years of age.
- Subject has developed a febrile disease with new neurological findings <4 days prior to the current hospitalization.
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- Subject has had an oral temperature of >38 degrees Celsius within 48 hours of study entry.
- Subject must have one or more of the following acute signs at the time of study entry:
- Signs of meningitis (nuchal rigidity)
- Signs of encephalitis (changes in mental status)
- Evidence of brainstem, cranial nerve, or cerebellar dysfunction
- Limb weakness.
- Subject must have a CSF examination within 48 hours of study entry showing:
- Absence of any organisms on Gram or fungal stains
- White blood cell count of > 4 per mm3 (corrected for significant red blood cell contamination)
- Ratio of CSF glucose: plasma glucose of >0.40; and CSF protein >30 mg/dL
- Subjects with reproductive potential must agree to practice adequate birth control methods to protect themselves and their partners from conception as defined below:
- Men with reproductive potential are eligible to participate if they use an acceptable method of contraception (such as a condom with spermicide).
- Women with childbearing potential are eligible to participate if they are surgically sterile (via hysterectomy or bilateral tubal ligation) at least one year post-menopausal, or are using an acceptable method of contraception (such as oral, topical, or injected contraception, IUD, Nuva-Ring®, or double barrier method such as diaphragm and condom with spermicide).
Who cannot join
- Subject (or family or legal guardian) requests Do Not Resuscitate or Do Not Intubate orders.
- Subject has multi-system organ failure at the time of screening or is not expected to survive the next 12 months due to another cause.
- Subject has a history of any vaccine administration <30 days prior to study entry.
- Subject has a possible history of traumatic neuritis <7 days prior to study entry (e.g., acupuncture, any needle-administered drugs, automobile accident, and/or blunt trauma).
- Subject is female and is pregnant or breastfeeding. (If the Subject is not postmenopausal or has not been surgically sterilized, a negative serum pregnancy test is required within 72 hours prior to the administration of the first dose of study drug.)
- Subject has any of the following clinically significant abnormal laboratory results:
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- Serum creatinine greater than 3.0 mg/dL or study Subject requires hemodialysis
- Liver function tests twice the upper limit of normal
- Total bilirubin level twice the upper limit of normal
- PT or INR twice the upper limit of normal
- Documented presence of bacterial or non-WNV viral agents in CSF
- Principal Investigator is of the opinion that the Subject's medical condition(s) or state of mental health would prevent adherence to protocol requirements or hinder interpretation of clinical study results.
About this study
Official title: An Exploratory Study of the Safety, Tolerability, Pharmacokinetics and Potential Effectiveness of AVI-4020 Injection in Patients Presenting With Presumptive Acute Neuroinvasive West Nile Virus (WNV) Disease
Although the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive disease, is rare, it can result in permanent disabilities and occasionally death. For patients who get this serious form of WNV disease, there are no approved specific treatment options.
The purpose of this study is to test a new drug, AVI-4020 Injection, in patients who are hospitalized with recent symptoms of this form of WNV disease. In this study, we will determine if the AVI-4020 treatment is safe. This will be accomplished by reviewing the results of laboratory tests and clinical signs and symptoms. Additionally, we will review the patient data for signs that AVI-4020 is providing any beneficial effects against WNV neuroinvasive disease.
Read the detailed description
- To evaluate the safety of intravenously administered (IV) AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance.
- To evaluate the tolerability of intravenously administered AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance.
- To evaluate the effectiveness of intravenously administered AVI-4020 Injection at 45 mg every 12 hours for ten doses, based on the neurological status of each study Subject as measured by a combination of the NIH stroke scale score and the Glasgow coma scale score.
- To evaluate the robustness of the potential effectiveness of intravenously administered AVI-4020 Injection every 12 hours for ten doses over the course of 35 days of active surveillance, based on a variety of criteria, e.g., clinical, laboratory and/or neurophysiological results.
- Conditions
- West Nile Fever
- Being tested
- AVI-4020 Injection
- Keywords
- West Nile Fever Myelitis, West Nile Fever Encephalitis, West Nile Fever Meningitis, West Nile Fever Meningoencephalitis
- Medical subject headings
- West Nile Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVI-4020 InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessments will be based on evaluations of treatment emergent adverse events (TEAE), serious adverse events (SAE), serial clinical examinations, and serial conventional laboratory tests.
Secondary outcomes (1)
A secondary endpoint is the potential effectiveness of AVI-4020 Injection based on the neurological status measured by a combination of the NIH Stroke Scale and the Glasgow Coma Score (GCS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2004 (estimated)
- Study startNov 2004
- Study completionNov 2004
Why it stopped: Due to limited pool of eligble WNV patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for West Nile FeverStudies of the same condition, open and under way.
- More trials run by Sarepta Therapeutics, Inc.The sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarepta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091845
- Sponsor's protocol ID
- AVI-4020-14
- Status last verified
- Jul 2009
- First submitted
- 17 Sep 2004
- Last updated
- 8 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Safety, Tolerability, Pharmacokinetics and Potential Effectiveness of AVI-4020 Injection in Patients Presenting With Presumptive Acute Neuroinvasive West Nile Virus (WNV) Disease
- ClinicalTrials.gov ID
- NCT00091845
- Acronym / sponsor ID
- AVI-4020-14
- Conditions
- West Nile Fever
- Keywords
- West Nile Fever Myelitis, West Nile Fever Encephalitis, West Nile Fever Meningitis, West Nile Fever Meningoencephalitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to limited pool of eligble WNV patients
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sarepta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Nov 2004 (actual)
- First posted
- 21 Sep 2004 (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.
Although the serious form of West Nile Virus (WNV) disease, referred to as neuroinvasive disease, is rare, it can result in permanent disabilities and occasionally death. For patients who get this serious form of WNV disease, there are no approved specific treatment options.
The purpose of this study is to test a new drug, AVI-4020 Injection, in patients who are hospitalized with recent symptoms of this form of WNV disease. In this study, we will determine if the AVI-4020 treatment is safe. This will be accomplished by reviewing the results of laboratory tests and clinical signs and symptoms. Additionally, we will review the patient data for signs that AVI-4020 is providing any beneficial effects against WNV neuroinvasive disease.
Detailed description
- To evaluate the safety of intravenously administered (IV) AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance.
- To evaluate the tolerability of intravenously administered AVI-4020 Injection every 12 hours for a total of ten doses over the course of study surveillance.
- To evaluate the effectiveness of intravenously administered AVI-4020 Injection at 45 mg every 12 hours for ten doses, based on the neurological status of each study Subject as measured by a combination of the NIH stroke scale score and the Glasgow coma scale score.
- To evaluate the robustness of the potential effectiveness of intravenously administered AVI-4020 Injection every 12 hours for ten doses over the course of 35 days of active surveillance, based on a variety of criteria, e.g., clinical, laboratory and/or neurophysiological results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject has a positive serum or CSF ELISA MAC-IgM test indicating active/recent WNV infection, or the Subject resides in or has traveled to geographic areas with at least one of the following characteristics within the last seven days:
- Subject is between >18 and <75 years of age.
- Subject has developed a febrile disease with new neurological findings <4 days prior to the current hospitalization.
- Subject has had an oral temperature of >38 degrees Celsius within 48 hours of study entry.
- Subject must have one or more of the following acute signs at the time of study entry:
Key exclusion criteria (12 listed)
- Subject (or family or legal guardian) requests Do Not Resuscitate or Do Not Intubate orders.
- Subject has multi-system organ failure at the time of screening or is not expected to survive the next 12 months due to another cause.
- Subject has a history of any vaccine administration <30 days prior to study entry.
- Subject has a possible history of traumatic neuritis <7 days prior to study entry (e.g., acupuncture, any needle-administered drugs, automobile accident, and/or blunt trauma).
- Subject is female and is pregnant or breastfeeding. (If the Subject is not postmenopausal or has not been surgically sterilized, a negative serum pregnancy test is required within 72 hours prior to the administration of the first dose of study drug.)
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 |
|---|---|---|
| AVI-4020 Injection | Drug | – |
Primary outcome
Safety and tolerability assessments will be based on evaluations of treatment emergent adverse events (TEAE), serious adverse events (SAE), serial clinical examinations, and serial conventional laboratory tests.
1 secondary outcome
A secondary endpoint is the potential effectiveness of AVI-4020 Injection based on the neurological status measured by a combination of the NIH Stroke Scale and the Glasgow Coma Score (GCS).
Results and safety
The study was stopped early (reason given: Due to limited pool of eligble WNV patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVI-4020 Injection in people with West Nile Fever, run by Sarepta Therapeutics, Inc..
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 19 inclusion and 12 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 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Due to limited pool of eligble WNV patients). 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?
Safety and tolerability assessments will be based on evaluations of treatment emergent adverse events (TEAE), serious adverse events (SAE), serial clinical examinations, and serial conventional laboratory tests.. 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 8 Jul 2009.