HYQVIA for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Inflammatory Demyelinating Polyradiculoneuropathy+2 More
HYQVIA - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Study Objectives

30 Primary · 0 Secondary · Reporting Duration: Throughout the study period of approximately 7 years

Hour 72
Number of Adverse Events (AEs) Temporally Associated with Infusions
Number of Infusions Temporally Associated with Adverse Events (AEs)
Year 7
Incidence of Binding Antibodies to rHuPH20
Incidence of Neutralizing Antibodies to rHuPH20
Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions
Number of Infusions Associated with Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs)
Number of Infusions Associated with One or More Local Infusion Site Reactions
Number of Infusions Associated with One or More Systemic Adverse Events (AEs)
Number of Infusions Associated with Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs)
Number of Infusions Associated with Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion was Interrupted or Stopped due to Intolerability and/or Adverse Events (AEs)
Incest (event)
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs)
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions
Therapeutic procedure
Number of Participants in whom Infusion Rate was Reduced and/or the Infusion was Interrupted or Stopped due to Intolerability and/or Adverse Events (AEs)
Number of Participants who have Greater than (>) 10,000 Titer of Binding Antibodies to rHuPH20: Neutralizing Antibodies and Cross Reactivity with Hyal-1,2 and 4
Number of Participants whose Anti-Hyaluronidase Antibody Titers Rise by Greater Than or Equal (> or =) ( 4 Fold from the Original Baseline Value from Study 161403 Using Combined Data from Both Studies (161403 and 161505)
Number of Participants with Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate per Site, and Infusion Volume per Site
Number of Participants with Serious and/or Non-Serious Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Number of Participants with Treatment-Emergent with Local Tolerability Events
Number of Participants with a Decline of Anti-rHuPH20 Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or Study 161601 and/or to Less than (<)160 at the Study Completion or Early Discontinuation
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study
Number of Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions
Number of Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions, Regardless of Causality
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Rate per Infusion of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Rates of Causally Related Systemic and Local Adverse Events (AEs)
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Side Effects for

Arm B (Temsirolimus)
75%Fatigue
65%Anemia
48%Hyperglycemia
43%Lymphocyte count decreased
38%Anorexia
35%Constipation
35%Cough
35%Platelet count decreased
35%Nausea
30%Pain
30%Mucositis oral
28%White blood cell decreased
28%Hypoalbuminemia
28%Dyspnea
25%Hypertriglyceridemia
25%Alanine aminotransferase increased
25%Cholesterol high
23%Dysphagia
20%Depression
20%Fever
20%Weight loss
20%Hypophosphatemia
18%Hyponatremia
18%Insomnia
18%Alkaline phosphatase increased
18%Aspartate aminotransferase increased
18%Hypocalcemia
18%Hypokalemia
18%Headache
18%Non-cardiac chest pain
15%Peripheral sensory neuropathy
15%Creatinine increased
15%Vomiting
15%Edema face
15%Neck pain
13%Rash maculo-papular
13%Diarrhea
13%Dysgeusia
13%Rash acneiform
13%Infections and infestations - Other
10%Dizziness
10%Edema limbs
10%Arthralgia
10%Neutrophil count decreased
8%INR increased
8%Respiratory failure
8%Facial pain
8%Anxiety
8%Back pain
8%Pneumonitis
8%Hypertension
8%Dry mouth
8%Dry skin
8%Pruritus
8%Neck edema
8%Oral dysesthesia
5%Generalized muscle weakness
5%Sore throat
5%Hypomagnesemia
5%Tumor pain
5%General disorders and administration site conditions - Other
5%Urinary frequency
5%Myalgia
5%Hypernatremia
5%Chills
5%Dehydration
5%Ear pain
5%Epistaxis
5%Hypercalcemia
5%Hearing impaired
5%Pleural effusion
5%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%Allergic rhinitis
5%Skin infection
5%Gastroesophageal reflux disease
5%Dyspepsia
5%Leukocytosis
5%Papulopustular rash
5%Hyperkalemia
5%Lung infection
5%Lymphedema
5%Sinusitis
3%Blurred vision
3%Anorectal infection
3%Peripheral motor neuropathy
3%Oral pain
3%Respiratory, thoracic and mediastinal disorders - Other
3%Skin and subcutaneous tissue disorders - Other
3%Laryngeal obstruction
3%Vertigo
3%Pleuritic pain
3%Palmar-plantar erythrodysesthesia syndrome
3%Stridor
3%Tracheostomy site bleeding
3%Alopecia
3%Postnasal drip
3%Eye disorders - Other
3%Hypoxia
3%Heart failure
3%Pharyngeal hemorrhage
3%Tracheal hemorrhage
3%Pleural infection
3%Pneumothorax
3%Skin ulceration
3%Hypotension
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01256385) in the Arm B (Temsirolimus) ARM group. Side effects include: Fatigue with 75%, Anemia with 65%, Hyperglycemia with 48%, Lymphocyte count decreased with 43%, Anorexia with 38%.

Trial Design

1 Treatment Group

HYQVIA
1 of 1
Experimental Treatment

85 Total Participants · 1 Treatment Group

Primary Treatment: HYQVIA · No Placebo Group · Phase 3

HYQVIA
Biological
Experimental Group · 1 Intervention: HYQVIA · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study period of approximately 7 years

Who is running the clinical trial?

Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
8,991 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
46 Previous Clinical Trials
11,190 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
138 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study DirectorStudy DirectorTakeda
1,055 Previous Clinical Trials
473,456 Total Patients Enrolled
4 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
7,259 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
If female, the participant must have a negative pregnancy test at baseline and agree to use birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.
The subject has finished the first stage of the study without their CIDP getting worse.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas50.0%
California50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Arizona Neuromuscular Research Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%