IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02881437
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Lille
• Public title: IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
• Scientific title: Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia
• Date of first enrolment: November 11, 2016
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02881437
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Eric Hachulla, MD, PhD
• Affiliation: University Hospital, Lille

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subject at least 18 years old at the time inclusion.

- Suffering from PI requiring immunoglobulin replacement therapy.

- Treated with SCIG at stable dose for at least 3 months at the time of inclusion.

- Well balanced SCIG treatment according to the investigator at the time of inclusion.

- If female of childbearing potential, the subject must have a negative blood or urine
pregnancy test at the time of inclusion and must agree to employ adequate birth
control measures during the whole study.

- Willing and able to comply with the requirements of the protocol.

- Having signed the informed consent form.

Exclusion Criteria:

- Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60
mL/min/1.73m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration
(CKD-EPI) equation at the time of screening.

- Having received a chemotherapy or immunomodulating therapy for either malignant or
chronic inflammatory disease for over 6 months.

- Receiving anticoagulant therapy.

- Having abnormal protein loss (protein losing enteropathy, nephrotic syndrome).

- Know allergy to hyaluronidase.

- Family member or employee of the investigator.

- Having participated in another interventional clinical study involving an
investigational product (IP) or investigational device within 30 days prior to
inclusion or scheduled to participate in another clinical study involving an another
investigational product or investigational device during the course of this study.

- If female, pregnant or breastfeeding at the time of enrolment.

- If female, planning to become pregnant during the time period of the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency

Intervention(s)

Drug: IgHy10

Primary Outcome(s)

The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1). [Time Frame: Every 2 weeks during the baseline (visit 1) and the 3 months (visit3)]

Secondary Outcome(s)

The Short Form (36) Health Survey [Time Frame: at 6 months]

Number of adverse reactions [Time Frame: 6 months]

Number of infection [Time Frame: 6 months]

The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3). [Time Frame: Every 3 weeks after the 3 months (visit 3) as 6 months ( visit 4)]

Incidence rate of adverse reactions [Time Frame: 6 months]

Treatment Satisfaction Questionnaire for Medication (TSQM-9). [Time Frame: at 6 months]

Secondary ID(s)

2015_31

2016-001480-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shire