Clinical trial NCT02955355: Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2016-11-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Any Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), Regardless of Causality
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With Causally Related Treatment-emergent SAEs and AEs
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With Adverse Reactions (ARs) or Suspected Adverse Reactions (SARs) Categorized as Serious and Non-serious
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Percentage of Participants With Treatment-Emergent Adverse Events That May be a Result of Immune-Mediated Responses
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Treatment-Emergent SAEs and AEs Associated With Infusions, Regardless of Causality
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Causally Related Treatment-Emergent SAEs and AEs Associated With Infusions
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of TEAEs Temporally Associated With Infusions
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Serious and Non-Serious ARs or SARs Associated With Infusions
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Infusions Associated With One or More Systemic TEAEs
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Infusions Associated With One or More Local TEAEs
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or TEAEs
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Infusion
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Participant
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Infusion
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Participant
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per 1000 Participant-year
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Infusion
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Participant
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per 1000 Participant-year
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With a TEAE That Led to Discontinuation From Study
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Rate of Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses, Expressed as Number of Events Per 100 Infusions
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants That Experienced Treatment-Emergent Local Infusion Site Reactions
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With Treatment-Emergent Local Tolerability Events During Ramp-up
timeFrame: During the ramp-up (8 weeks)
measure: Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants Whose Anti-Hyaluronidase Binding Antibody Titers Rose by ≥4-fold From Baseline
timeFrame: Baseline, up to 6.6 years
measure: Number of Participants With Binding Antibodies to rHuPH20
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With Neutralizing Antibodies Binding to rHuPH20
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants With a Decline of Anti-rHuPH20 Binding Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or to <1:160 Antibody Titer Level at the Study Completion or Early Discontinuation
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
measure: Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers With Neutralizing Antibodies
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
Secondary outcomes:
measure: Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers Showing Cross Reactivity With Hyaluronidase (Hyal)-1,2 and 4
timeFrame: From the first dose of study drug up to end of study (up to 6.6 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Neuromuscular Research Center
state: Arizona
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hosp.Britanico de Buenos Aires
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba - Hospital Ecoville
state: Paraná
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Medellin
country: Colombia
facility: Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
state: Poruba
city: Prague 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Aarhus C
country: Denmark
facility: Århus Universitetshospital
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
city: Bordeaux Cedex
country: France
facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin
state: Gironde
city: Bron Cedex
country: France
facility: Hopital Neurologique Pierre Wertheimer
state: Rhone
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoeR
state: Sachsen
city: Patras
country: Greece
facility: University Hospital of Patra
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Casimiro Mondino
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
state: Distrito Federal
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Denizli
country: Turkey
facility: Pamukkale Uni. Med. Fac.
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine
city: Konya
country: Turkey
facility: Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
city: Manisa
country: Turkey
facility: Celal Bayar University Medical Faculty
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: Liverpool
country: United Kingdom
facility: The Walton Centre
state: Merseyside
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: