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Immunoglobulin Replacement Therapy

HYQVIA for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

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

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
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6.6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6.6 years for reporting.

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 more

Side effects data

From 2021 Phase 4 trial • 42 Patients • NCT03116347
32%
Rhinitis
32%
Cough
16%
Pyrexia
16%
Upper respiratory tract infection
11%
Epistaxis
11%
Oropharyngeal pain
11%
Pneumonia
11%
Respiratory tract infection
5%
Contusion
5%
Rhinorrhoea
5%
Solar urticaria
5%
Sinusitis
5%
Bronchiectasis
5%
Blood immunoglobulin G decreased
5%
Haemangioma
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

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
9,013 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
138 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,716 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
138 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study DirectorStudy DirectorTakeda
1,260 Previous Clinical Trials
503,277 Total Patients Enrolled
5 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
6,380 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
~10 spots leftby Oct 2025
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