Immune Globulin Subcutaneous (Human) (IGSC), 20%

• Research type

  Research Study

• Full title

  A Clinical Study Of Immune Globulin Subcutaneous (Human)(Igsc), 20% For The Evaluation Of Efficacy, Safety, And Pharmacokinetics In Subjects With Primaryimmunodeficiency Diseases

• IRAS ID

  60992

• Contact name

  Sofia Grigoriadou

• Sponsor organisation

  Baxter Innovations GmbH

• Eudract number

  2010-019459-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Humans are protected from infection by anti-bodies. Some people produce abnormal antibodies which do not protect them from infection. This disease is called Primary Immunodeficiency Diseases (PID.)PID patients are very susceptible to infections caused by bacteria which means that they can suffer from minor infections such as runny nose and cough or more serious infections requiring antibiotics or even hospitalisation. Patients miss time from school or work as a result of repeated infections causing distress and loss of income in the case of adults.Purified human antibody preparations were first used in the 1950s for the replacement therapy of patients with PID. Studies have clearly demonstrated that antibody replacement reduces the number and severity of patients?? symptoms and infections. Since the 1980s, a majority of patients have been receiving antibody therapy directly into the veins of the body. However, side effects and the need for experienced medical personnel to give the treatment have been problems for many patients.Sub cutuaneous (SC) administration (given under the skin) antibody replacement therapy is considered to be effective, safe, and also highly appreciated by patients as it has a relatively low risk of side effects. After adequate training by healthcare professionals, SC infusions of antibody replacement therapy can easily be performed by the patient at home, thus increasing the health-related quality of life and reducing costs for the healthcare sector. The purpose of this study is to test a new concentrated liquid preparation (IGSC, 20%). The high concentration leads to smaller infusion volumes compared to the currently licensed products. 47 subjects with PID including a minimum of 20 subjects aged between 2 and 18 years will be recruited. The patients will be in the study for approximately 1 year and 4 months.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/99

• Date of REC Opinion

  21 Dec 2010

• REC opinion

  Further Information Favourable Opinion