NCT01617317|CompletedDMC
H-IVIG Treatment for Severe H1N1 2009
Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
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Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
Sponsor study identifier
interventional
34
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)Study Completion
May 2012
Actual (reported)Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 2011
Actual (reported)May 2012
Actual (reported)June 2, 2012
Actual (reported)June 12, 2012
Actual (reported)Mortality
From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months
Adverse events
From date of randomization until the date of first documented adverse events due to treatment, assessed up to 1 week
ICU length of stay
Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Hospital length of stay
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Nasopharyngeal viral load
One day before randomization and up to 5 days after treatment
Cytokine/ chemokine
One day before randomization and up to 5 days after treatment
Single intravenous infusion of 0.4g/kg of simple IVIG which contain no H1N1 2009 antibody (manufactured before 2009).
Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG fractionated from convalescent plasma (H1N1 2009 antibody titer was 1:320 by hemagglutination inhibition and neutralizing antibody assays)
Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG
Single intravenous infusion of 0.4g/kg of simple IVIG
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
Hung IF, To KK, Lee CK, Lin CK, Chan JF, Tse H, Cheng VC, Chen H, Ho PL, Tse CW, Ng TK, Que TL, Chan KH, Yuen KY. Effect of clinical and virological parameters on the level of neutralizing antibody against pandemic influenza A virus H1N1 2009. Clin Infect Dis. 2010 Aug 1;51(3):274-9. doi: 10.1086/653940.
Ivan FN Hung, MD FRCP
The University of Hong Kong
34 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2012
First Posted
June 12, 2012
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
To KK, Hung IF, Li IW, Lee KL, Koo CK, Yan WW, Liu R, Ho KY, Chu KH, Watt CL, Luk WK, Lai KY, Chow FL, Mok T, Buckley T, Chan JF, Wong SS, Zheng B, Chen H, Lau CC, Tse H, Cheng VC, Chan KH, Yuen KY. Delayed clearance of viral load and marked cytokine activation in severe cases of pandemic H1N1 2009 influenza virus infection. Clin Infect Dis. 2010 Mar 15;50(6):850-9. doi: 10.1086/650581.
Wu JT, Lee CK, Cowling BJ, Yuen KY. Logistical feasibility and potential benefits of a population-wide passive-immunotherapy program during an influenza pandemic. Proc Natl Acad Sci U S A. 2010 Feb 16;107(7):3269-74. doi: 10.1073/pnas.0911596107. Epub 2010 Feb 1.
Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion. 2010 Sep;50(9):1967-71. doi: 10.1111/j.1537-2995.2010.02651.x.
Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.
Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.
Hung IFN, To KKW, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CCY, Liu SH, Chan KH, Lin CK, Yuen KY. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013 Aug;144(2):464-473. doi: 10.1378/chest.12-2907.
Primary Completion
November 2011
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
June 12, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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