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

IDENTIFIERS
Trial Protocol: 161505
Clinicaltrials.gov: NCT02955355
EudraCT: 2016-000374-37
PURPOSE

The purpose of this study is to assess the long-term safety, tolerability, and immunogenicity of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous (IGSC) facilitated with recombinant human hyaluronidase (rHuPH20) (HYQVIA/HyQvia) in participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) who have completed Baxalta Clinical Study Protocol 161403 Epoch 1 without CIDP worsening.

Recruiting
US
AR
BR
15+
CA
CO
CZ
DK
FR
DE
GR
IT
MX
PL
RS
SK
ES
TR
GB

Trial at a glance

What medical condition is being studied?   Chronic inflammatory demyelinating polyradiculoneuropathy
What is the trial testing?   HYQVIA
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

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Trial Phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
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).
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

Any
Recruiting
Terminated
Any
RESULTS
Arizona Neuromuscular Research Center

4545 E Shea Blvd, Phoenix, AZ 85028, USA

Recruiting
6,250 miles (10,059 km)  awayfrom
Новосибирск, Новосибирская область
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Hosp.Britanico de Buenos Aires

Perdriel 74, C1280 AEB, Buenos Aires, Argentina

Recruiting
10,121 miles (16,288 km)  awayfrom
Новосибирск, Новосибирская область
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Instituto de Neurologia de Curitiba - Hospital Ecoville

Rua Jeremias Maciel Perretto, 300 - Campo Comprido, Curitiba - PR, 81210-310, Brazil

Recruiting
9,288 miles (14,947 km)  awayfrom
Новосибирск, Новосибирская область
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University of Alberta Hospital

8440 112 St NW, Edmonton, AB T6G 2B7, Canada

Recruiting
4,878 miles (7,850 km)  awayfrom
Новосибирск, Новосибирская область
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LHSC - University Hospital

339 Windermere Rd, London, ON N6A 5A5, Canada

Recruiting
5,599 miles (9,010 km)  awayfrom
Новосибирск, Новосибирская область
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Toronto General Hospital, University Health Network

190 Elizabeth St, Toronto, ON M5G 2C4, Canada

Recruiting
5,539 miles (8,914 km)  awayfrom
Новосибирск, Новосибирская область
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Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

Cl. 69 ##51c-24, Medellín, Antioquia, Colombia

Recruiting
8,024 miles (12,913 km)  awayfrom
Новосибирск, Новосибирская область
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Fakultni nemocnice Ostrava

17. listopadu 1790, 708 00 Ostrava-Poruba, Czechia

Recruiting
2,652 miles (4,268 km)  awayfrom
Новосибирск, Новосибирская область
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Recruiting
2,784 miles (4,480 km)  awayfrom
Новосибирск, Новосибирская область
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CHU de Nice

30 Voie Romaine, 06000 Nice, France

Recruiting
3,316 miles (5,337 km)  awayfrom
Новосибирск, Новосибирская область
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Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Place Amélie Raba Léon, 33076 Bordeaux, France

Recruiting
3,553 miles (5,718 km)  awayfrom
Новосибирск, Новосибирская область
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Hopital Neurologique Pierre Wertheimer

59 Boulevard Pinel, 69500 Bron, France

Recruiting
3,312 miles (5,330 km)  awayfrom
Новосибирск, Новосибирская область
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Universitaetsklinikum Leipzig AoeR

Liebigstraße 18, 04103 Leipzig, Germany

Recruiting
2,806 miles (4,515 km)  awayfrom
Новосибирск, Новосибирская область
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University Hospital of Patra

Rio 265 04, Greece

Recruiting
3,007 miles (4,840 km)  awayfrom
Новосибирск, Новосибирская область
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Azienda Ospedaliero Universitaria San Martino

Largo Rosanna Benzi, 10, 16132 Genova GE, Italy

Recruiting
3,222 miles (5,185 km)  awayfrom
Новосибирск, Новосибирская область
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Azienda Ospedaliera Universitaria Policlinico G. Martino

Via Consolare Valeria, 1, 98124 Messina ME, Italy

Recruiting
3,260 miles (5,246 km)  awayfrom
Новосибирск, Новосибирская область
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Fondazione Istituto Neurologico Casimiro Mondino

Via Mondino, 2, 27100 Pavia PV, Italy

Recruiting
3,180 miles (5,118 km)  awayfrom
Новосибирск, Новосибирская область
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Azienda Ospedaliero Universitaria Pisana

Via Roma, 67, 56126 Pisa PI, Italy

Recruiting
3,199 miles (5,149 km)  awayfrom
Новосибирск, Новосибирская область
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Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Piazzale Santa Maria della Misericordia, 15, 33100 Udine UD, Italy

Recruiting
2,989 miles (4,810 km)  awayfrom
Новосибирск, Новосибирская область
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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

Recruiting
7,300 miles (11,748 km)  awayfrom
Новосибирск, Новосибирская область
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Uniwersyteckie Centrum Kliniczne

Dębinki 7, 80-952 Gdańsk, Poland

Recruiting
2,475 miles (3,983 km)  awayfrom
Новосибирск, Новосибирская область
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Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Jaczewskiego 8, 20-954 Lublin, Poland

Recruiting
2,436 miles (3,920 km)  awayfrom
Новосибирск, Новосибирская область
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Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

Dr. Stefana Kopcińskiego 22, 90-001 Łódź, Poland

Recruiting
2,532 miles (4,074 km)  awayfrom
Новосибирск, Новосибирская область
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Clinical Center of Serbia

Pasterova 2, Beograd 11000, Serbia

Recruiting
2,767 miles (4,453 km)  awayfrom
Новосибирск, Новосибирская область
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Military Medical Academy

Crnotravska 17, Beograd 11000, Serbia

Recruiting
2,768 miles (4,455 km)  awayfrom
Новосибирск, Новосибирская область
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Clinical Center Nis

Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia

Recruiting
2,774 miles (4,465 km)  awayfrom
Новосибирск, Новосибирская область
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Fakultna nemocnica Nitra

Špitálska 6, 950 01 Nitra, Slovakia

Recruiting
2,714 miles (4,368 km)  awayfrom
Новосибирск, Новосибирская область
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Hospital Universitari Vall d'Hebron

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

Recruiting
3,615 miles (5,818 km)  awayfrom
Новосибирск, Новосибирская область
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Pamukkale Uni. Med. Fac.

Çamlaraltı, Pamukkale Ünv. Hastane Yolu, 20070 Kınıklı/Pamukkale/Denizli, Turkey

Recruiting
2,744 miles (4,416 km)  awayfrom
Новосибирск, Новосибирская область
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Dokuz Eylul University Faculty of Medicine

İnciraltı, Otopark, 35330 Balçova/İzmir, Turkey

Recruiting
2,795 miles (4,499 km)  awayfrom
Новосибирск, Новосибирская область
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Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

Ardıçlı, Akademi, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya, Turkey

Recruiting
2,596 miles (4,178 km)  awayfrom
Новосибирск, Новосибирская область
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Celal Bayar University Medical Faculty

Şehit Prof. Dr. İlhan Varank Kampüsü, Yağcılar, 45140 Yunusemre/Manisa, Turkey

Recruiting
2,771 miles (4,459 km)  awayfrom
Новосибирск, Новосибирская область
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King's College Hospital

Denmark Hill, Herne Hill, London SE5 9RS, UK

Recruiting
3,234 miles (5,204 km)  awayfrom
Новосибирск, Новосибирская область
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The Walton Centre

Lower Ln, Liverpool L9 7LJ, UK

Recruiting
3,241 miles (5,216 km)  awayfrom
Новосибирск, Новосибирская область
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Århus Universitetshospital

P. P. Ørums Gade 11, 8000 Aarhus, Denmark

Terminated/Withdrawn
2,706 miles (4,355 km)  awayfrom
Новосибирск, Новосибирская область
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View all (35)
Trial Protocol ID: 161505
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