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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 : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:
The purpose of this phase IIIb 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.

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 : 148 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, 2023
Estimated Study Completion Date : September 30, 2023


Arm Intervention/treatment
Experimental: 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.
Biological: HYQVIA
Participants will receive subcutaneous (SC) HYQVIA/HyQvia which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
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 7 years ]
    Number of participants experiencing any treatment-emergent SAEs and/or AEs, regardless of causality will be assessed. An AE is defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.

  2. 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 experiencing causally related SAEs and/or AEs will be assessed.

  3. 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 ]
    Number of participants with serious and/or non-serious ARs plus suspected ARs will be assessed. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or an AE that begins during infusion of IP or within 72 hours following the end of IP infusion, or an AE for which causality assessment is missing or indeterminate.

  4. Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses [ Time Frame: Throughout the study period of approximately 7 years ]
    Rate of AEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex mediated reactions -local, Immune complex mediated reactions-systemic which will be expressed as the number of events per infusion and per participant-year will be assessed.

  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 7 years ]
    Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Number of infusions associated with treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs), regardless of causality will be assessed.

  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 7 years ]
    Number of infusions associated with causally related serious adverse events (SAEs) and/or adverse events (AEs) will be assessed.

  7. Number of Infusions Temporally Associated with Adverse Events (AEs) [ Time Frame: During or within 72 hours after completion of an infusion ]
    Number of infusions temporally associated with AEs defined as AEs occurring during or within 72 hours after completion of an infusion will be assessed.

  8. 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 serious and/or non-serious ARs plus suspected ARs will be assessed.

  9. 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 1 or more systemic AEs will be assessed.

  10. 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 associated with 1 or more local infusion site reactions will be assessed.

  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 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 AEs will be assessed.

  12. Rates of Systemic and local Adverse Events (AEs), Regardless of Causality [ Time Frame: Throughout the study period of approximately 7 years ]
    Rates of systemic and local AEs, regardless of causality will be expressed as number of events per infusion, per participant, and per participant-year.

  13. Rates of Causally Related Systemic and Local Adverse Events (AEs) [ Time Frame: Throughout the study period of approximately 7 years ]
    Rates of causally related systemic and local AEs, will be expressed as number of events per infusion, per participant, and per participant-year.

  14. Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs) [ Time Frame: Throughout the study period of approximately 7 years ]
    Rates of systemic and local adverse reactions (ARs) plus suspected ARs, will be expressed as number of events per infusion, per participant, and per participant-year.

  15. 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 participants with an adverse event (AE) that led to discontinuation from study will be assessed.

  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 7 years ]
    Number of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.

  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 7 years ]
    Rate per infusion of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.

  18. Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions [ Time Frame: Throughout the study period of approximately 7 years ]
    Number of participants experiencing treatment-emergent local infusion site reactions will be assessed. All local infusion site treatment-emergent AEs will be reported as adverse reactions.

  19. Number of Participants with Treatment-Emergent with Local Tolerability Events [ Time Frame: Throughout the study period of approximately 7 years ]
    Number of participants with treatment-emergent with local tolerability events during the first 8 weeks of open-label extension study 161505 among participants originally randomized to placebo (no ramp up), versus during the 8 week-ramp-up period for participants originally randomized to HYQVIA in double-blind Study 161403 will be assessed.

  20. 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 in whom infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.

  21. 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 experiencing local infusion reactions, as a function of dosing interval, infusion rate per site, and infusion volume per site will be assessed.

  22. 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 ]
    Number of participants whose anti-hyaluronidase antibody titers rise by > or = 4 fold from the original baseline value from study 161403 using combined data from both studies (161403 and 161505) will be assessed.

  23. Incidence of Binding Antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 7 years ]
    Incidence of binding antibodies to rHuPH20 will be assessed.

  24. Incidence of Neutralizing Antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 7 years ]
    Incidence of neutralizing antibodies to rHuPH20 will be assessed.

  25. 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 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 will be assessed.

  26. 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 ]
    Number of participants who have >10,000 titer of binding antibodies to rHuPH20: neutralizing antibodies and cross reactivity with Hyal-1,2 and 4 will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

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: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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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    
Other Study ID Numbers: 161505
2016-000374-37 ( EudraCT Number )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
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