Clinical trial
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)
Name
161505
Description
Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.
The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia.
All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so.
Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.
Trial arms
Trial start
2016-12-12
Estimated PCD
2023-07-04
Trial end
2023-07-04
Status
Completed
Phase
Early phase I
Treatment
HYQVIA
Participants will receive subcutaneous (SC) HYQVIA/HyQvia which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Arms:
HYQVIA
Other names:
IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) (IGI 10%) with recombinant human hyaluronidase (rHuPH20)
Size
85
Primary endpoint
Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality
Throughout the study period of approximately 7 years
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs)
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)
Throughout the study period of approximately 7 years
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
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
Throughout the study period of approximately 7 years
Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions
Throughout the study period of approximately 7 years
Number of Adverse Events (AEs) Temporally Associated with Infusions
During or within 72 hours after completion of an infusion
Number of Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions
Throughout the study period of approximately 7 years
Number of Infusions Associated with One or More Systemic Adverse Events (AEs)
Throughout the study period of approximately 7 years
Number of Infusions Associated with One or More Local Infusion Site Reactions
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)
Throughout the study period of approximately 7 years
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality
Throughout the study period of approximately 7 years
Rates of Causally Related Systemic and Local Adverse Events (AEs)
Throughout the study period of approximately 7 years
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Throughout the study period of approximately 7 years
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study
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
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
Throughout the study period of approximately 7 years
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions
Throughout the study period of approximately 7 years
Number of Participants with Treatment-Emergent with Local Tolerability Events
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)
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
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)
Throughout the study period of approximately 7 years
Incidence of Binding Antibodies to rHuPH20
Throughout the study period of approximately 7 years
Incidence of Neutralizing Antibodies to rHuPH20
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
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
Throughout the study period of approximately 7 years
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 85, 'type': 'ACTUAL'}}
Updated at
2023-07-24
1 organization
1 product
1 indication
Organization
ShireProduct
HYQVIA