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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE December 12, 2016
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • Number of infusions associated with 1 or more systemic adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  • Number of infusions associated with 1 or more local infusion site reactions [ Time Frame: Throughout the study period of approximately 5 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 5 years ]
  • Rates of systemic and local AEs, regardless of causality [ Time Frame: Throughout the study period of approximately 5 years ]
  • Rates of Causally Related Systemic and Local Adverse Events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  • Rates of systemic and local adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout the study period of approximately 5 years ]
  • Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study [ Time Frame: Throughout the study period of approximately 5 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 5 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 5 years ]
  • Incidence of Binding Antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 5 years ]
  • Incidence of Neutralizing Antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 5 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 [ Time Frame: Throughout the study period of approximately 5 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 [ Time Frame: Throughout the study period of approximately 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intervention  ICMJE 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)
Study Arms  ICMJE 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.
Intervention: Biological: HYQVIA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2019)
148
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
149
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com
Listed Location Countries  ICMJE Canada,   Czechia,   Denmark,   France,   Greece,   Italy,   Serbia,   Slovakia,   Spain,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02955355
Other Study ID Numbers  ICMJE 161505
2016-000374-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Shire ( Baxalta now part of Shire )
Study Sponsor  ICMJE Baxalta now part of Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Shire
PRS Account Shire
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP