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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02955355
• Date of registration: 02/11/2016
• Prospective Registration: Yes
• Primary sponsor: Baxalta now part of Shire
• Public title: Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
• Scientific 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)
• Date of first enrolment: December 12, 2016
• Target sample size: 85
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02955355
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Poland, Serbia, Slovakia, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention(s)

Biological: HYQVIA

Primary Outcome(s)

Incidence of Neutralizing Antibodies to rHuPH20 [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 Experiencing Treatment-Emergent Local Infusion Site Reactions [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]

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 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 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 Infusions Associated with One or More Local Infusion Site Reactions [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]

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 Infusions Associated with One or More Systemic Adverse Events (AEs) [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]

Number of Adverse Events (AEs) Temporally Associated with Infusions [Time Frame: During or within 72 hours after completion of an infusion]

Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study [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]

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 Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions [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 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 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 with Treatment-Emergent with Local Tolerability Events [Time Frame: Throughout the study period of approximately 7 years]

Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions [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]

Number of Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions, Regardless of Causality [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]

Secondary ID(s)

161505

2016-000374-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Development Center Americas, Inc.