Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.

The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia.

All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so.

Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Intervention / Treatment: Biological: HYQVIA

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, 1280
    • Hosp.Britanico de Buenos Aires
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba - Hospital Ecoville
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • LHSC - University Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital, University Health Network
• Colombia
  • Medellin, Colombia, 050010
    • Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
• Czechia
  • Prague 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Poruba
    • Ostrava, Poruba, Czechia, 708 52
      • Fakultni Nemocnice Ostrava
• Denmark
  • Aarhus C, Denmark, 8000
    • Århus Universitetshospital
• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06002
      • CHU de Nice
  • Gironde
    • Bordeaux Cedex, Gironde, France, 33076
      • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • Rhone
    • Bron Cedex, Rhone, France, 69677
      • Hôpital Neurologique Pierre Wertheimer
• Germany
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig AoeR
• Greece
  • Patras, Greece, 26504
    • University Hospital of Patra
• Italy
  • Genova, Italy, 16132
    • Azienda Ospedaliero Universitaria San Martino
  • Messina, Italy, 98122
    • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Pavia, Italy, 27100
    • Fondazione Istituto Neurologico Casimiro Mondino
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Udine, Italy, 33100
    • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Lublin, Poland, 20-090
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Łódź, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Nis, Serbia, 18000
    • Clinical Center Nis
• Slovakia
  • Nitra, Slovakia, 95001
    • Fakultná nemocnica Nitra
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale Uni. Med. Fac.
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Faculty of Medicine
  • Konya, Turkey, 42075
    • Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
  • Manisa, Turkey, 45030
    • Celal Bayar University Medical Faculty
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • King's College Hospital
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7LJ
      • The Walton Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85028
      • Arizona Neuromuscular Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has completed Epoch 1 of Study 161403 without CIDP worsening.
2. If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate 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.

Exclusion Criteria:

1. Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study.
2. New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study.
3. Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this study.
4. The participant is nursing or intends to begin nursing during the course of the study
5. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study 161403) involving an IP or investigational device during the course of this study.
6. The participant is a family member or employee of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HYQVIA; 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).	Biological: HYQVIA; Participants will receive subcutaneous (SC) HYQVIA/HyQvia which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).; Other Names: IGI 10% with rHuPH20; Immune Globulin Infusion 10% (Human) (IGI 10%) with recombinant human hyaluronidase (rHuPH20)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality	Number of participants experiencing any treatment-emergent SAEs and/or AEs, regardless of causality will be assessed. An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.	Throughout the study period of approximately 7 years
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs)	Number of participants experiencing causally related SAEs and/or AEs will be assessed.	Throughout the study period of approximately 7 years
Number of Participants with Serious and/or Non-Serious Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)	Number of participants with serious and/or non-serious ARs plus suspected ARs will be assessed. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or an AE that begins during infusion of IP or within 72 hours following the end of IP infusion, or an AE for which causality assessment is missing or indeterminate.	Throughout the study period of approximately 7 years
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses	Rate of AEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex mediated reactions -local, Immune complex mediated reactions-systemic which will be expressed as the number of events per infusion and per participant-year will be assessed.	Throughout the study period of approximately 7 years
Number of Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions, Regardless of Causality	Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Number of treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions, regardless of causality will be assessed.	Throughout the study period of approximately 7 years
Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions	Number of causally related serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions will be assessed.	Throughout the study period of approximately 7 years
Number of Adverse Events (AEs) Temporally Associated with Infusions	Number of AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion will be assessed.	During or within 72 hours after completion of an infusion
Number of Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions	Number of serious and/or non-serious ARs plus suspected ARs associated with infusions will be assessed.	Throughout the study period of approximately 7 years
Number of Infusions Associated with One or More Systemic Adverse Events (AEs)	Number of infusions associated with 1 or more systemic AEs will be assessed.	Throughout the study period of approximately 7 years
Number of Infusions Associated with One or More Local Infusion Site Reactions	Number of infusions associated with 1 or more local infusion site reactions will be assessed.	Throughout the study period of approximately 7 years
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)	Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.	Throughout the study period of approximately 7 years
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality	Rates of systemic and local AEs, regardless of causality will be expressed as number of events per infusion, per participant, and per participant-year.	Throughout the study period of approximately 7 years
Rates of Causally Related Systemic and Local Adverse Events (AEs)	Rates of causally related systemic and local AEs, will be expressed as number of events per infusion, per participant, and per participant-year.	Throughout the study period of approximately 7 years
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)	Rates of systemic and local adverse reactions (ARs) plus suspected ARs, will be expressed as number of events per infusion, per participant, and per participant-year.	Throughout the study period of approximately 7 years
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study	Number of participants with an adverse event (AE) that led to discontinuation from study will be assessed.	Throughout the study period of approximately 7 years
Number of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses	Number of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.	Throughout the study period of approximately 7 years
Rate per Infusion of Moderate or Severe 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 will be assessed.	Throughout the study period of approximately 7 years
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions	Number of participants experiencing treatment-emergent local infusion site reactions will be assessed. All local infusion site treatment-emergent AEs will be reported as adverse reactions.	Throughout the study period of approximately 7 years
Number of Participants with Treatment-Emergent with Local Tolerability Events	Number of participants with treatment-emergent with local tolerability events during the first 8 weeks of open-label extension study 161505 among participants originally randomized to placebo (no ramp up), versus during the 8 week-ramp-up period for participants originally randomized to HYQVIA in double-blind Study 161403 will be assessed.	Throughout the study period of approximately 7 years
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 in whom infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.	Throughout the study period of approximately 7 years
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 experiencing local infusion reactions, as a function of dosing interval, infusion rate per site, and infusion volume per site will be assessed.	Throughout the study period of approximately 7 years
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 whose anti-hyaluronidase antibody titers rise by > or = 4 fold from the original baseline value from study 161403 using combined data from both studies (161403 and 161505) will be assessed.	Throughout the study period of approximately 7 years
Incidence of Binding Antibodies to rHuPH20	Incidence of binding antibodies to rHuPH20 will be assessed.	Throughout the study period of approximately 7 years
Incidence of Neutralizing Antibodies to rHuPH20	Incidence of neutralizing antibodies to rHuPH20 will be assessed.	Throughout the study period of approximately 7 years
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 a decline of anti-rHuPH20 antibody titers to the antibody titer level at baseline in Study 161403 or Study 161601 and/or to <160 at the study completion or early discontinuation will be assessed.	Throughout the study period of approximately 7 years
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 who have >10,000 titer of binding antibodies to rHuPH20: neutralizing antibodies and cross reactivity with Hyal-1,2 and 4 will be assessed.	Throughout the study period of approximately 7 years

Collaborators and Investigators

• Sponsor: Baxalta now part of Shire
• Collaborators: Takeda Development Center Americas, Inc.
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): July 4, 2023
• Study Completion (Actual): July 4, 2023

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimated): November 4, 2016

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Chronic Disease; Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulins
• Other Study ID Numbers: 161505; 2016-000374-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No