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View Clinical Trial (Medical Research Study)
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A Randomized Open Label Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza A H1N1 Immune Plasma for the Treatment of Influenza A H1N1 2009 - NCT01052480-20892 (Clinical Trial 478998)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy478998.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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H1N1 Influenza - Swine Flu |
| Purpose: |
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Influenza A/H1N1 2009 (commonly referred to as "swine flu") is a novel influenza virus.
Most people will not have immunity to it. H1N1 vaccines are available, but currently in
limited supply. As of 17 October 2009, worldwide there have been more than 414,000
laboratory confirmed cases of pandemic influenza H1N1 2009 and nearly 5000 deaths reported
to the World Health Organization (WHO). Initial reports suggested a high mortality rate (6-7
percent). Recent statistics suggest a mortality rate could be as high as 1.2 percent (5000
deaths in 400,000 cases), though most countries are no longer collecting and reporting mild
cases of H1N1. Mortality likely remains significantly higher than seasonal influenza.
Severe morbidity and mortality occurs despite treatment with current antivirials.
Additionally, circulating H1N1 isolates are highly resistant to amantadine and rimantadine,
and so there is concern this virus may also acquire oseltamivir resistance that is seen in
circulating seasonal H1N1 virus.
This randomized, open label, multi-center phase 2 trial will assess the safety, efficacy,
and pharmacokinetics of H1N1 plasma in subjects with H1N1 influenza. Hospitalized subjects
with influenza A at risk for severe disease (as defined in the inclusion criteria) will be
eligible for study participation. In addition to adults, this study will enroll children and
pregnant women, though these groups will be brought on in stepwise manner after DSMB safety
reviews.
Approximately 40 sites in the United States will be utilized for this protocol. 100
eligible subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric
equivalent) of H1N1 plasma on Study Day 0 in addition to standard care or standard care
alone (50 subjects receiving standard care alone; 50 subjects receiving H1N1 plasma).
Subjects will be assessed on Study Day 0 (pre-dose), 1 hour post-dose, and on Study Days 2,
4, 7, 14, and 28. All subjects will undergo a series of efficacy, safety, and PK (H1N1 HAI)
assessments during the study. Blood samples will be collected at each time point.
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| Study summary: |
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Influenza A/H1N1 2009 (commonly referred to as "swine flu") is a novel influenza virus.
Most people will not have immunity to it. H1N1 vaccines are available, but currently in
limited supply. As of 17 October 2009, worldwide there have been more than 414,000
laboratory confirmed cases of pandemic influenza H1N1 2009 and nearly 5000 deaths reported
to the World Health Organization (WHO). Initial reports suggested a high mortality rate (6-7
percent). Recent statistics suggest a mortality rate could be as high as 1.2 percent (5000
deaths in 400,000 cases), though most countries are no longer collecting and reporting mild
cases of H1N1. Mortality likely remains significantly higher than seasonal influenza.
Severe morbidity and mortality occurs despite treatment with current antivirials.
Additionally, circulating H1N1 isolates are highly resistant to amantadine and rimantadine,
and so there is concern this virus may also acquire oseltamivir resistance that is seen in
circulating seasonal H1N1 virus.
This randomized, open label, multi-center phase 2 trial will assess the safety, efficacy,
and pharmacokinetics of H1N1 plasma in subjects with H1N1 influenza. Hospitalized subjects
with influenza A at risk for severe disease (as defined in the inclusion criteria) will be
eligible for study participation. In addition to adults, this study will enroll children and
pregnant women, though these groups will be brought on in stepwise manner after DSMB safety
reviews.
Approximately 40 sites in the United States will be utilized for this protocol. 100
eligible subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric
equivalent) of H1N1 plasma on Study Day 0 in addition to standard care or standard care
alone (50 subjects receiving standard care alone; 50 subjects receiving H1N1 plasma).
Subjects will be assessed on Study Day 0 (pre-dose), 1 hour post-dose, and on Study Days 2,
4, 7, 14, and 28. All subjects will undergo a series of efficacy, safety, and PK (H1N1 HAI)
assessments during the study. Blood samples will be collected at each time point. |
| Criteria: |
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- INCLUSION CRITERIA:
Subjects must meet all of the following criteria to participate in the study:
1. Provide written informed consent before initiation of any study procedures. Informed
consent should be obtained from the subject, or if a subject is judged by the
investigator to be unable to provide informed consent, consent should be obtained
from his/her legally authorized representative. If the consent is obtained from the
subject, an informed consent capacity assessment should be obtained. This assessment
may use the standard assessment tool provided in Appendix A, or any assessment tool
that is approved by the site IRB/IEC. If a subject is unable to provide informed
consent, as judged by the investigator, it may only be obtained from the subject's
legally authorized representative if allowed by local regulation and must be in
accordance with local requirements.
2. Diagnosis of influenza A (confirmed by local assay including rapid antigen, DFA, PCR,
or culture, and may test for either influenza A or more specific influenza A H1N1
(2009))
3. Hospitalization for signs and symptoms of influenza (decision for hospitalization
will be up to the individual treating clinician).
4. Organ Dysfunction Score that meets the following criteria:
- SOFA Score for age greater than or equal to 18 years of at least 3 points
- PELOD Score for age less than 18 years of at least 3 points
5. Treatment of influenza with antiviral drugs. (i.e subjects that are not sick enough
to be given antivirals would not be eligible for this study)
6. Agree to the storage of specimens and data
7. ABO compatible H1N1 plasma available
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria will be excluded from study participation:
Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to
receive anytime during the study). This does not include licensed drugs at non-approved
doses, off-label indications, or drugs available under an Emergency Use Authorization
(EUA).
Symptoms or signs of the acute influenza like illness have occurred for more than 14 days
prior to enrollment.
History of severe allergic reaction to blood products (as judged by the investigator).
Medical conditions for which receipt of 500cc volume (or 8 mL/kg for pediatric patients)
may be dangerous to the subject (e.g. decompensated CHF, etc) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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