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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
CA
CZ
DK
8+
FR
GR
IT
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
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

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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

Any
Recruiting
Terminated
Any
RESULTS
Toronto General Hospital, University Health Network

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

Recruiting
386 miles (622 km)  awayfrom
Massachusetts, United States
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Fakultni nemocnice Ostrava

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

Recruiting
4,084 miles (6,572 km)  awayfrom
Massachusetts, United States
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Fakultni nemocnice v Motole, Dept of Neurologicka klinika 2. LF UK a FN Motol

V Úvalu 84, 150 06 Praha 5, Czechia

Recruiting
3,927 miles (6,321 km)  awayfrom
Massachusetts, United States
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Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Place Amélie Raba Léon, 33076 Bordeaux, France

Recruiting
3,457 miles (5,564 km)  awayfrom
Massachusetts, United States
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Hopital Neurologique Pierre Wertheimer, Pathologies neuro-musculaires. Electromyographie

59 Boulevard Pinel, 69500 Bron, France

Recruiting
3,673 miles (5,911 km)  awayfrom
Massachusetts, United States
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University of Patras Medical School

Rio 265 04, Greece

Recruiting
4,678 miles (7,529 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliera Universitaria Policlinico G. Martino, UOC Neuropatologia

Via Consolare Valeria, 1, 98124 Messina ME, Italy

Recruiting
4,408 miles (7,095 km)  awayfrom
Massachusetts, United States
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Fondazione Istituto Neurologico Casimiro Mondino, Unità Complessa Malattie Cerebrovascolari/Stroke U

Via Mondino, 2, 27100 Pavia PV, Italy

Recruiting
3,873 miles (6,233 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliero Universitaria Pisana, Dipartimento di Neuroscienze

Via Roma, 67, 56126 Pisa PI, Italy

Recruiting
3,977 miles (6,400 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, U.O. di Neurologia

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

Recruiting
4,016 miles (6,463 km)  awayfrom
Massachusetts, United States
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Clinical Center of Serbia, Clinic of Neurology

Pasterova 2, Beograd 11000, Serbia

Recruiting
4,360 miles (7,017 km)  awayfrom
Massachusetts, United States
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Military Medical Academy

Crnotravska 17, Beograd 11000, Serbia

Recruiting
4,362 miles (7,020 km)  awayfrom
Massachusetts, United States
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Clinical Center Nis

Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia

Recruiting
4,478 miles (7,207 km)  awayfrom
Massachusetts, United States
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Fakultna nemocnica Nitra, Ambulancia pre nervosvalové ochorenia

Špitálska 6, 950 01 Nitra, Slovakia

Recruiting
4,135 miles (6,654 km)  awayfrom
Massachusetts, United States
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Hospital Universitari Vall d'Hebron, Neurology Dept.

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

Recruiting
3,684 miles (5,929 km)  awayfrom
Massachusetts, United States
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Pamukkale Uni. Med. Fac., Emergency Medicine

Çamlaraltı, Hüseyin Yılmaz Cd. 65 A, 20160 Merkez/Pamukkale/Denizli, Turkey

Recruiting
5,012 miles (8,066 km)  awayfrom
Massachusetts, United States
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Dokuz Eylul University Faculty of Medicine, Neurology Department

No: 144 35210, Alsancak, Cumhuriyet Blv, 35220 Konak/İzmir, Turkey

Recruiting
4,900 miles (7,885 km)  awayfrom
Massachusetts, United States
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Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi, Brain and Nerve Surgery

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

Recruiting
5,139 miles (8,271 km)  awayfrom
Massachusetts, United States
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The Walton Centre, Dept of Neurology

Lower Ln, Liverpool L9 7LJ, UK

Recruiting
3,157 miles (5,081 km)  awayfrom
Massachusetts, United States
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Århus Universitetshospital, Neurologisk

Nørrebrogade 44, 8000 Aarhus C, Denmark

3,594 miles (5,784 km)  awayfrom
Massachusetts, United States
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View all (20)
Trial Protocol ID: 161505
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