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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 throughout the study period of approximately 7 years
Awards & highlights

Study Summary

This trial is for adults with CIDP who have completed study 161403 and are looking to see the long-term effects of HYQVIA/HyQvia.

Eligible Conditions
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study period of approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study period of approximately 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Binding Antibodies to rHuPH20
Incidence of Neutralizing Antibodies to rHuPH20
Number of Adverse Events (AEs) Temporally Associated with Infusions
+23 more

Side effects data

From 2021 Phase 4 trial • 42 Patients • NCT03116347
32%
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%
Eye pain
5%
Infusion site pain
5%
Fatigue
5%
Blood immunoglobulin G decreased
5%
Inflammatory bowel disease
5%
Impetigo
5%
Haemangioma
5%
Bacterial infection
5%
Radius fracture
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

1Treatment groups
Experimental Treatment
Group I: HYQVIAExperimental Treatment1 Intervention
Subjects will continue to receive HYQVIA/HyQvia infusions every 2, or 3, or 4 weeks (±3 days) following the same dose and dosing regimen of the Phase 3 pivotal study (Study 161403).
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
9,019 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
11,945 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
138 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study DirectorStudy DirectorTakeda
1,208 Previous Clinical Trials
489,610 Total Patients Enrolled
4 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
6,350 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you compare and contrast HYQVIA's efficacy against other immunoglobulin treatments?

"There are currently 79 clinical trials underway that involve HYQVIA. Of these, 34 are in Phase 3. Although the majority of these studies originated in Lebanon, New hampshire, there are 3887 total locations running trials for this medication."

Answered by AI

What conditions does HYQVIA commonly treat?

"HYQVIA is a Bruton's agammaglobulinemia treatment, but it can also help with other issues like breast cancer, drug extravasation, and high risk of recurrence."

Answered by AI

Has the FDA cleared HYQVIA for use?

"HYQVIA received a score of 3 on our safety scale. This is because it is a Phase 3 trial, meaning that there is not only some efficacy data but also multiple rounds of data supporting safety."

Answered by AI

Would you like to enroll in this clinical trial?

"The clinical trial you are inquiring about is not presently recruiting patients, according to the information found on clinicaltrials.gov. This study was first posted on December 12th, 2016 and last updated March 21st, 2022. Although this specific trial is not currently looking for new participants, there are 98 other studies that are."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Arizona Neuromuscular Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
2016. "Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02955355.
~10 spots leftby Apr 2025
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