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Immunoglobulin Replacement Therapy
HYQVIA for Primary Immunodeficiency
Phase 3
Waitlist Available
Research Sponsored by Baxalta now part of Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study epoch 2, year 1: months 0, 6, and 12; year 2: months 18, 24 and 36
Awards & highlights
Study Summary
This trial is studying HYQVIA to see if it is effective, safe, and tolerated in children with primary immunodeficiency disease.
Eligible Conditions
- Primary Immunodeficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study epoch 2, year 1: months 0, 6, and 12; year 2: months 18, 24 and 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study epoch 2, year 1: months 0, 6, and 12; year 2: months 18, 24 and 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate Represented as Mean Number of Acute Serious Bacterial Infections (ASBI) Per Participant-year
Secondary outcome measures
Epoch 1: Number of Weeks to Reach Final Dose Interval
Epoch 2: Apparent Clearance (CL/F)
Epoch 2: Area Under the Curve Normalized for Week (AUCweek)
+43 moreSide effects data
From 2021 Phase 4 trial • 42 Patients • NCT0311634732%
Rhinitis
32%
Cough
16%
Upper respiratory tract infection
16%
Pyrexia
11%
Pneumonia
11%
Respiratory tract infection
11%
Epistaxis
11%
Oropharyngeal pain
5%
Diarrhoea
5%
Contusion
5%
Conjunctival haemorrhage
5%
Infusion site pain
5%
Haemangioma
5%
Fatigue
5%
Blood immunoglobulin G decreased
5%
Eye pain
5%
Inflammatory bowel disease
5%
Bacterial infection
5%
Radius fracture
5%
Impetigo
5%
Neutropenia
5%
Nasopharyngitis
5%
Pharyngotonsillitis
5%
Sinusitis
5%
Bronchiectasis
5%
Solar urticaria
5%
Pilonidal cyst
5%
Dental caries
5%
Acute sinusitis
5%
Otitis media
5%
Rhinorrhoea
5%
Dysmenorrhoea
5%
Idiopathic orbital inflammation
5%
Vomiting
5%
Application site pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
HyQvia Pre-treated
HyQvia New Starters
Trial Design
2Treatment groups
Experimental Treatment
Group I: Epoch 2Experimental Treatment1 Intervention
Epoch 1 was followed by Epoch 2 with HYQVIA treatment infusions given once every 3 or 4 weeks, depending on the participant's previous IV dosing schedule (for IV pretreated participants) and at the discretion of the investigator and participant (for SC-pretreated participants) up to approximately 36 months.
Group II: Epoch 1Experimental Treatment1 Intervention
Pediatric participants with PIDD who were on IV or non-HYQVIA SC treatment with immunoglobulin were enrolled and treated with HYQVIA SC with a dose or interval ramp-up period of up to six weeks. HYQVIA dose was planned to be equivalent to 100% (± 5%) of pre-study treatment. Dose frequency was one treatment interval of one week, then one treatment interval of two weeks for participants who were planned to be treated every three weeks, and one more treatment interval of three weeks for participants who were planned to be treated every four weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved
Find a Location
Who is running the clinical trial?
Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
9,060 Total Patients Enrolled
Baxalta Innovations GmbH, now part of ShireIndustry Sponsor
18 Previous Clinical Trials
7,976 Total Patients Enrolled
Study DirectorStudy DirectorShire
1,211 Previous Clinical Trials
489,228 Total Patients Enrolled
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