Clinical Trial Results:
Open Label Phase II Multicenter Study for the Evaluation of Pharmacokinetics of VENBIG (Human Immunoglobulin anti-Hepatitis B for Intravenous Use) and IMMUNOHBS (Human Immunoglobulin anti Hepatitis B for Intramuscular Use) Administered to HBsAg Negative Patients After Orthotopic Liver Transplantation. Evaluation of Safety and Efficacy of IMMUNOHBS performed in all the patients enrolled in the Pharmacokinetic Study
Summary
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EudraCT number |
2005-000840-10 |
Trial protocol |
IT |
Global completion date |
22 Jun 2007
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
19 May 2017
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First version publication date |
19 May 2017
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Other versions |
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Summary report(s) |
KB036SynopsisCSR |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.