Tolerability and Safety of IG, 10% with rHuPH20 in PIDD
Research type
Research Study
Full title
Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treatment with Immune Globulin (Human), 10% in Subjects with Primary Immunodeficiency Diseases – A Study in Europe
IRAS ID
101651
Contact name
Stephen Jolles
Sponsor organisation
Baxter Innovations GmbH
Eudract number
2012-000481-38
ISRCTN Number
N/A
Research summary
This is a phase II/III multicenter European study to evaluate tolerability and safety and other parameters of treatment using immunoglobulin (IG) 10% with rHuPH20. Both medicines are given as an injection under the skin (subcutaneously). The IG is the therapeutic product under test, whilst the sole purpose of the rHuPH20 is to increase the absorption of the IG by breaking down barriers to absorption found under the skin surface. Approximately 40 subjects with Primary Immunodeficiency Diseases (PIDD) will be included. To be selected, patients must have previously received immunoglobulin products immediately prior to entering the study. The study is open-label i.e. both patients and investigators know what treatments the patients are receiving and there is no blinding of treatments or placebo. There are three treatment Epochs (stages) in the study and doses will be given at either 1-, 2-, 3- or 4-weekly intervals during the study. The dose will be based on ??weekly equivalents?Â: one ??weekly equivalent? is the pre-study dose received over a period of 4 weeks, divided by 4. Infusions will be conducted generally at the study site, but there will be an option for this to occur at the subject's home. The subject participation period is approximately 7 months from enrolment (including the screening period) to subject completion (i.e. last study visit), unless prematurely discontinued.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
12/NE/0162
Date of REC Opinion
28 Jun 2012
REC opinion
Further Information Favourable Opinion