Immunoglobulin deficiency and recurrent infections with chronic fatigue syndrome MedDRA version: 19.0 Level: PT Classification code 10008874 Term: Chronic fatigue syndrome System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 19.0 Level: LLT Classification code 10021485 Term: Immunoglobulin G decreased System Organ Class: 100000004848
Conditions
Interventions
Trade Name: HyQvia
Product Name: HyQvia
Pharmaceutical Form: Infusion
INN or Proposed INN: HyQvia
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: % percent
Concentration type: equal
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 -65 years, both genders • immunoglobulin deficiency, with indication for immunoglobulin substitution therapy • recurrent bacterial or viral infections: > 4 infections per year, other than common cold • CFS (performance status 12 g/dl male, >11g/dl female), normal or slightly reduced leucocytes (>3/nl), normal thrombocytes (150 - 370/nl) • Normal PTT and INR/Quick • normal renal function: serum creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Other serious underlying medical conditions which could impair the ability of the patient to participate in the study • Women of childbearing potential meeting any one of the following criteria o subject presents with a positive pregnancy test o subject is breast feeding o subject intends to begin nursing during the course of the study • Subject has participated in another clinical study and has been exposed to an investigational product (IP) or device within 30 days prior to study enrollment (exception: treatment with immunoglobulin pre-study) • Subject is scheduled to participate in another interventional clinical study involving an IP or device during the course of the study • Subject has known hypersensitivity to any of the components of the medicinal product • Severe dermatitis that would preclude adequate sites for safe product administration • Subject is a family member or employee of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to improve chronic fatigue syndrome in patients with chronic immunodeficiency and recurrent infections ;Secondary Objective: • to ameliorate the frequency and severity of infections • to assess the tolerability of HyQvia in patients with CFS and patients contentment with handling of self IgG application and the mechanical pump • to identify biomarkers for responsenter information in English and add any other language that is applicable;Primary end point(s): Efficacy to improve fatigue, assessed by: • CFS Symptom Scale • SF-36 physical functioning ;Timepoint(s) of evaluation of this end point: After 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Efficacy to control infections documented by patients diary (type of infection, symptoms, duration, severity, days missing work, antibiotics, hospitalization) • Functional assessment of fatigue by measuring muscle strength, composition of body tissues by bioimpedance, vessel function by flow mediated dilatation and activity tracking. • Additional questionaires to assess symptoms and physical functioning: CFS symptom scoring and COMPASS-31 • Immune marker of response. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Germany
Contacts
Public ContactForschungsbereich Med. Immunologie
Institut für Medizinische Immunologie
Outcome results
None listed