Trial at a glance
What medical condition is being studied? Chronic Inflammatory Demyelinating Polyradiculoneuropathy
What is the trial testing? HYQVIA
Are placebos part of the trial? No
How many participants are being enrolled? 149
When is the trial being conducted? -
How long is participation in the trial? Enrollment into this study is open to participants who have completed Study 161403 Epoch 1 without CIDP worsening and who have provided informed consent. Participants must meet all eligibility criteria in order to participate in this Extension Study. In this Extension Study, eligible participants will receive HYQVIA/HyQvia in an open-label fashion until relapse or until predetermined study end for the specific country from which the participant is participating.
Key requirements
Sex
All
Age
From 18 Years
Accepts Healthy Volunteers?
No
Trial Details / Participation Requirements
CLICK TO EXPANDCLICK TO COLLAPSE
Trial phase: Phase 3
Trial Type: Interventional
Trial Arms/Groups or Cohorts:
HYQVIA: All study Participants will receive SC HYQVIA/HyQvia at a dose of 80 Unit per gram (U/g) subcutaneously (SC) administered at a dosing frequency of every 2, 3, or 4 weeks interval for the first two doses and then for every 12 weeks until relapse or until predetermined study end for the specific country.
Intervention: HYQVIA
Primary Outcome Measure(s):
Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality [Time Frame: Throughout the study period of approximately 7 years]
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) [Time Frame: 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) [Time Frame: Throughout the study period of approximately 7 years]
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses [Time Frame: Throughout the study period of approximately 7 years]
Number of Infusions Associated with Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality [Time Frame: Throughout the study period of approximately 7 years]
Number of Infusions Associated with Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) [Time Frame: Throughout the study period of approximately 7 years]
Number of Infusions Temporally Associated with Adverse Events (AEs) [Time Frame: During or within 72 hours after completion of an infusion]
Number of Infusions Associated with Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) [Time Frame: Throughout the study period of approximately 7 years]
Number of Infusions Associated with One or More Systemic Adverse Events (AEs) [Time Frame: Throughout the study period of approximately 7 years]
Number of Infusions Associated with One or More Local Infusion Site Reactions [Time Frame: 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) [Time Frame: Throughout the study period of approximately 7 years]
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality [Time Frame: Throughout the study period of approximately 7 years]
Rates of Causally Related Systemic and Local Adverse Events (AEs) [Time Frame: Throughout the study period of approximately 7 years]
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs) [Time Frame: Throughout the study period of approximately 7 years]
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study [Time Frame: 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 [Time Frame: 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 [Time Frame: Throughout the study period of approximately 7 years]
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions [Time Frame: Throughout the study period of approximately 7 years]
Number of Participants with Treatment-Emergent with Local Tolerability Events [Time Frame: 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) [Time Frame: 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 [Time Frame: 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) [Time Frame: Throughout the study period of approximately 7 years]
Incidence of Binding Antibodies to rHuPH20 [Time Frame: Throughout the study period of approximately 7 years]
Incidence of Neutralizing Antibodies to rHuPH20 [Time Frame: 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 [Time Frame: 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 [Time Frame: Throughout the study period of approximately 7 years]
Entry 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 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
Trial Locations
RESULTS
Arizona Neuromuscular Research Center
4545 E Shea Blvd, Phoenix, AZ 85028, USA
Site Contact
Recruiting
5,801 miles (9,336 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Hosp.Britanico de Buenos Aires
Perdriel 74, C1280 AEB, Buenos Aires, Argentina
Site Contact
Recruiting
11,475 miles (18,467 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Instituto de Neurologia de Curitiba - Hospital Ecoville
Rua Jeremias Maciel Perretto, 300 - Campo Comprido, Curitiba - PR, 81210-310, Brazil
Recruiting
11,547 miles (18,583 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
University of Alberta Hospital
8440 112 St NW, Edmonton, AB T6G 2B7, Canada
Site Contact
Recruiting
4,887 miles (7,864 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
LHSC - University Hospital
339 Windermere Rd, London, ON N6A 5A5, Canada
Recruiting
6,405 miles (10,307 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Toronto General Hospital, University Health Network
190 Elizabeth St, Toronto, ON M5G 2C4, Canada
Site Contact
Recruiting
6,414 miles (10,323 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
Cl. 69 ##51c-24, Medellín, Antioquia, Colombia
Site Contact
Recruiting
8,753 miles (14,086 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Fakultni nemocnice Ostrava
17. listopadu 1790, 708 00 Ostrava-Poruba, Czechia
Site Contact
Recruiting
5,460 miles (8,787 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Fakultni nemocnice v Motole
V Úvalu 84, 150 06 Praha 5, Czechia
Site Contact
Recruiting
5,565 miles (8,957 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Recruiting
6,115 miles (9,842 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Place Amélie Raba Léon, 33076 Bordeaux, France
Site Contact
Recruiting
6,273 miles (10,096 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Hopital Neurologique Pierre Wertheimer
59 Boulevard Pinel, 69500 Bron, France
Site Contact
Recruiting
6,072 miles (9,772 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Universitaetsklinikum Leipzig AoeR
Liebigstraße 18, 04103 Leipzig, Germany
Site Contact
Recruiting
5,558 miles (8,944 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Recruiting
5,890 miles (9,479 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Azienda Ospedaliero Universitaria San Martino
Largo Rosanna Benzi, 10, 16132 Genova GE, Italy
Site Contact
Recruiting
6,027 miles (9,699 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Azienda Ospedaliera Universitaria Policlinico G. Martino
Via Consolare Valeria, 1, 98124 Messina ME, Italy
Site Contact
Recruiting
6,134 miles (9,871 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Fondazione Istituto Neurologico Casimiro Mondino
Via Mondino, 2, 27100 Pavia PV, Italy
Site Contact
Recruiting
5,978 miles (9,621 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Azienda Ospedaliero Universitaria Pisana
Via Roma, 67, 56126 Pisa PI, Italy
Site Contact
Recruiting
6,019 miles (9,687 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia, 15, 33100 Udine UD, Italy
Site Contact
Recruiting
5,805 miles (9,343 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Vasco de Quiroga 15, Belisario Domínguez Secc 16, Tlalpan, 14080 Ciudad de México, CDMX, Mexico
Site Contact
Recruiting
7,054 miles (11,352 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Uniwersyteckie Centrum Kliniczne
Dębinki 7, 80-952 Gdańsk, Poland
Site Contact
Recruiting
5,227 miles (8,411 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Jaczewskiego 8, 20-954 Lublin, Poland
Site Contact
Recruiting
5,252 miles (8,452 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Dr. Stefana Kopcińskiego 22, 90-001 Łódź, Poland
Site Contact
Recruiting
5,325 miles (8,570 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Clinical Center of Serbia
Pasterova 2, Beograd 11000, Serbia
Site Contact
Recruiting
5,627 miles (9,056 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Military Medical Academy
Crnotravska 17, Beograd 11000, Serbia
Site Contact
Recruiting
5,629 miles (9,059 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Clinical Center Nis
Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia
Site Contact
Recruiting
5,646 miles (9,087 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Fakultna nemocnica Nitra
Špitálska 6, 950 01 Nitra, Slovakia
Site Contact
Recruiting
5,537 miles (8,912 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Hospital Universitari Vall d'Hebron
Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain
Site Contact
Recruiting
6,396 miles (10,293 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Pamukkale Uni. Med. Fac.
Çamlaraltı, Pamukkale Ünv. Hastane Yolu, 20070 Kınıklı/Pamukkale/Denizli, Turkey
Site Contact
Recruiting
5,619 miles (9,043 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Dokuz Eylul University Faculty of Medicine
İnciraltı, Otopark, 35330 Balçova/İzmir, Turkey
Site Contact
Recruiting
5,676 miles (9,134 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
Ardıçlı, Akademi, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya, Turkey
Site Contact
Recruiting
5,462 miles (8,791 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Celal Bayar University Medical Faculty
Şehit Prof. Dr. İlhan Varank Kampüsü, Yağcılar, 45140 Yunusemre/Manisa, Turkey
Site Contact
Recruiting
5,652 miles (9,095 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
King's College Hospital
Denmark Hill, Herne Hill, London SE5 9RS, UK
Site Contact
Recruiting
5,872 miles (9,450 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
The Walton Centre
Lower Ln, Liverpool L9 7LJ, UK
Site Contact
Recruiting
5,816 miles (9,359 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
Århus Universitetshospital
P. P. Ørums Gade 11, 8000 Aarhus, Denmark
5,364 miles (8,633 km) awayfrom
æâ¥æŬ
æâ¥æŬ
View on Map
View all (35)
Trial Protocol ID: 161505
Back to Trial Summary