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Immunoglobulin Replacement Therapy
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 6.6 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial involves adults with CIDP who have previously participated in a study. They will receive HYQVIA/HyQvia, a medication that provides antibodies to help fight infections and reduce nerve inflammation. The main goal is to evaluate the long-term side effects of this treatment. HYQVIA/HyQvia is a combination of immune globulin infusion and recombinant human hyaluronidase, used to treat primary immunodeficiency and now being tested for CIDP.
Eligible Conditions
- CIDP
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 6.6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6.6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Causally Related Treatment-Emergent SAEs and AEs Associated With Infusions
Number of Infusions Associated With One or More Local TEAEs
Number of Infusions Associated With One or More Systemic TEAEs
+25 moreSide effects data
From 2021 Phase 4 trial • 42 Patients • NCT0311634732%
Rhinitis
32%
Cough
16%
Pyrexia
16%
Upper respiratory tract infection
11%
Epistaxis
11%
Oropharyngeal pain
11%
Pneumonia
11%
Respiratory tract infection
5%
Haemangioma
5%
Rhinorrhoea
5%
Sinusitis
5%
Contusion
5%
Solar urticaria
5%
Blood immunoglobulin G decreased
5%
Bronchiectasis
5%
Dysmenorrhoea
5%
Dental caries
5%
Inflammatory bowel disease
5%
Pilonidal cyst
5%
Eye pain
5%
Acute sinusitis
5%
Bacterial infection
5%
Impetigo
5%
Nasopharyngitis
5%
Idiopathic orbital inflammation
5%
Pharyngotonsillitis
5%
Conjunctival haemorrhage
5%
Diarrhoea
5%
Vomiting
5%
Fatigue
5%
Neutropenia
5%
Application site pruritus
5%
Infusion site pain
5%
Otitis media
5%
Radius fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
HyQvia Pre-treated
HyQvia New Starters
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: HYQVIA/HyQviaExperimental Treatment1 Intervention
Participants received HYQVIA/HyQvia (recombinant human hyaluronidase \[rHuPH20\] at a dose of 80 units per gram (U/g) immunoglobulin G \[IgG\], followed by subcutaneous \[SC\] immune globulin infusion \[IGI\] 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HYQVIA
2016
Completed Phase 4
~630
Find a Location
Who is running the clinical trial?
Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
8,980 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,688 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
502,427 Total Patients Enrolled