Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HYQVIA Subjects will continue to receive HYQVIA/HyQvia infusions every 2, or 3, or 4 weeks (±3 days) following the same dose and dosing regimen of the Phase 3 pivotal study (Study 161403). |
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:
|
Outcome Measures
Primary Outcome Measures
- 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 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 investigational product (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) [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) [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 [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 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]
Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Number of treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions, regardless of causality will be assessed.
- 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 causally related serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions will be assessed.
- Number of Adverse Events (AEs) Temporally Associated with Infusions [During or within 72 hours after completion of an infusion]
Number of AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion will be assessed.
- 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 serious and/or non-serious ARs plus suspected ARs associated with infusions will be assessed.
- 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 1 or more systemic AEs will be assessed.
- Number of Infusions Associated with One or More Local Infusion Site Reactions [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) [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 [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) [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) [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 [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 [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 [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 [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 [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) [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 [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) [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 [Throughout the study period of approximately 7 years]
Incidence of binding antibodies to rHuPH20 will be assessed.
- Incidence of Neutralizing Antibodies to rHuPH20 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has completed Epoch 1 of Study 161403 without CIDP worsening.
-
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:
-
Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study.
-
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.
-
Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this study.
-
The participant is nursing or intends to begin nursing during the course of the study
-
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
- involving an IP or investigational device during the course of this study.
- The participant is a family member or employee of the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Neuromuscular Research Center | Phoenix | Arizona | United States | 85028 |
| 2 | Hosp.Britanico de Buenos Aires | Ciudad Autonoma Buenos Aires | Argentina | 1280 | |
| 3 | Instituto de Neurologia de Curitiba - Hospital Ecoville | Curitiba | Paraná | Brazil | 81210-310 |
| 4 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 5 | LHSC - University Hospital | London | Ontario | Canada | N6A 5A5 |
| 6 | Toronto General Hospital, University Health Network | Toronto | Ontario | Canada | M5G 2C4 |
| 7 | Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA" | Medellin | Colombia | 050010 | |
| 8 | Fakultni nemocnice Ostrava | Ostrava | Poruba | Czechia | 708 52 |
| 9 | Fakultni nemocnice v Motole | Prague 5 | Czechia | 150 06 | |
| 10 | Århus Universitetshospital | Aarhus C | Denmark | 8000 | |
| 11 | CHU de Nice | Nice | Alpes Maritimes | France | 06002 |
| 12 | Groupe Hospitalier Pellegrin - Hôpital Pellegrin | Bordeaux Cedex | Gironde | France | 33076 |
| 13 | Hopital Neurologique Pierre Wertheimer | Bron Cedex | Rhone | France | 69677 |
| 14 | Universitaetsklinikum Leipzig AoeR | Leipzig | Sachsen | Germany | 04103 |
| 15 | University Hospital of Patra | Patras | Greece | 26504 | |
| 16 | Azienda Ospedaliero Universitaria San Martino | Genova | Italy | 16132 | |
| 17 | Azienda Ospedaliera Universitaria Policlinico G. Martino | Messina | Italy | 98122 | |
| 18 | Fondazione Istituto Neurologico Casimiro Mondino | Pavia | Italy | 27100 | |
| 19 | Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56126 | |
| 20 | Azienda Ospedaliero-Universitaria Santa Maria della Misericordia | Udine | Italy | 33100 | |
| 21 | Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran | Mexico | Distrito Federal | Mexico | 14080 |
| 22 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
| 23 | Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Lublin | Poland | 20-090 | |
| 24 | Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego | Łódź | Poland | 90-153 | |
| 25 | Clinical Center of Serbia | Belgrade | Serbia | 11000 | |
| 26 | Military Medical Academy | Belgrade | Serbia | 11000 | |
| 27 | Clinical Center Nis | Nis | Serbia | 18000 | |
| 28 | Fakultna nemocnica Nitra | Nitra | Slovakia | 95001 | |
| 29 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 30 | Pamukkale Uni. Med. Fac. | Denizli | Turkey | 20070 | |
| 31 | Dokuz Eylul University Faculty of Medicine | Izmir | Turkey | 35340 | |
| 32 | Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi | Konya | Turkey | 42075 | |
| 33 | Celal Bayar University Medical Faculty | Manisa | Turkey | 45030 | |
| 34 | King's College Hospital | London | Greater London | United Kingdom | SE5 9RS |
| 35 | The Walton Centre | Liverpool | Merseyside | United Kingdom | L9 7LJ |
Sponsors and Collaborators
- Baxalta now part of Shire
- Takeda Development Center Americas, Inc.
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 161505
- 2016-000374-37