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Trial record 36 of 49 for:    Polyneuropathies | CIDP

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

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ClinicalTrials.gov Identifier: NCT02955355
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:
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 or Clinical Study Protocol 161601 without CIDP worsening.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Biological: HYQVIA Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024


Arm Intervention/treatment
Experimental: All Study Participants Biological: HYQVIA
Other Names:
  • IGI 10% with rHuPH20
  • Immune Globulin Infusion 10% (Human) (IGI 10%) with recombinant human hyaluronidase (rHuPH20)




Primary Outcome Measures :
  1. 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 5 years ]
  2. Number of participants experiencing causally related serious adverse events (SAEs) and/or adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  3. Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout the study period of approximately 5 years ]
  4. Rate of adverse events (AEs) that may be a result of immune-mediated responses [ Time Frame: Throughout the study period of approximately 5 years ]
    Expressed as the number of events per infusion and per particpant-year

  5. 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 5 years ]
  6. Number of infusions associated with causally related serious adverse events (SAEs) and/or adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  7. Number of infusions temporally associated with adverse events (AEs) [ Time Frame: during or within 72 hours after completion of an infusion ]
    Defined as AEs occurring during or within 72 hours after completion of an infusion

  8. Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout the study period of approximately 5 years ]
  9. Number of infusions associated with 1 or more systemic adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  10. Number of infusions associated with 1 or more local infusion site reactions [ Time Frame: Throughout the study period of approximately 5 years ]
  11. 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 5 years ]
  12. Rates of systemic and local AEs, regardless of causality [ Time Frame: Throughout the study period of approximately 5 years ]
  13. Rates of causally related systemic and local adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  14. Rates of systemic and local adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout the study period of approximately 5 years ]
  15. Number of participants with an adverse event (AE) that led to discontinuation from study [ Time Frame: Throughout the study period of approximately 5 years ]
  16. 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 5 years ]
  17. 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 5 years ]
  18. Incidence of binding antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 5 years ]
  19. Incidence of neutralizing antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 5 years ]
  20. 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 [ Time Frame: Throughout the study period of approximately 5 years ]
  21. Number of participants who have >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 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has completed Epoch 1 of Study 161403 or Study 161601 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 or Study 161601 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 (with the exception of Study 161403 or Study 161601) or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
  6. The participant is a family member or employee of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955355


Contacts
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Contact: Andras Nagy 617-588-8362 andras.nagy@shire.com
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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Canada, Ontario
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Czechia
Fakultni nemocnice Ostrava Recruiting
Ostrava, Poruba, Czechia, 708 52
Fakultni nemocnice v Motole, Dept of Neurologicka klinika 2. LF UK a FN Motol Recruiting
Prague 5, Czechia, 150 06
Denmark
Århus Universitetshospital, Neurologisk Terminated
Aarhus C, Denmark, 8000
France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin Recruiting
Bordeaux Cedex, Gironde, France, 33076
Hopital Neurologique Pierre Wertheimer, Pathologies neuro-musculaires. Electromyographie Recruiting
Bron Cedex, Rhone, France, 69677
Greece
University of Patras Medical School Recruiting
Patras, Greece, 26504
Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino, UOC Neuropatologia Recruiting
Messina, Italy, 98122
Fondazione Istituto Neurologico Casimiro Mondino, Unità Complessa Malattie Cerebrovascolari/Stroke U Recruiting
Pavia, Italy, 27100
Azienda Ospedaliero Universitaria Pisana, Dipartimento di Neuroscienze Recruiting
Pisa, Italy, 56126
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, U.O. di Neurologia Recruiting
Udine, Italy, 33100
Serbia
Clinical Center of Serbia, Clinic of Neurology Recruiting
Belgrade, Serbia, 11000
Military Medical Academy Recruiting
Belgrade, Serbia, 11000
Clinical Center Nis Recruiting
Nis, Serbia, 18000
Slovakia
Fakultna nemocnica Nitra, Ambulancia pre nervosvalové ochorenia Recruiting
Nitra, Slovakia, 95001
Spain
Hospital Universitari Vall d'Hebron, Neurology Dept. Recruiting
Barcelona, Spain, 08035
Turkey
Pamukkale Uni. Med. Fac., Emergency Medicine Recruiting
Denizli, Turkey, 20070
Dokuz Eylul University Faculty of Medicine, Neurology Department Recruiting
Izmir, Turkey, 35340
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi, Brain and Nerve Surgery Recruiting
Konya, Turkey, 42075
United Kingdom
The Walton Centre, Dept of Neurology Recruiting
Liverpool, Merseyside, United Kingdom, L9 7LJ
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02955355     History of Changes
Other Study ID Numbers: 161505
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs