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

NCT ID: NCT02955355

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-14
• Study Completion Date: 2023-07-04

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HYQVIA/HyQvia

Participants received HYQVIA/HyQvia (recombinant human hyaluronidase \[rHuPH20\] at a dose of 80 units per gram (U/g) immunoglobulin G \[IgG\], followed by subcutaneous \[SC\] immune globulin infusion \[IGI\] 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.

Group Type: EXPERIMENTAL

HYQVIA

Intervention Type: BIOLOGICAL

Participants received HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).

Interventions

HYQVIA

Participants received HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).

Intervention Type: BIOLOGICAL

Other Intervention Names

10%) with recombinant human hyaluronidase (rHuPH20); Immune Globulin Infusion 10% (Human) (IGI; IGI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Arizona Neuromuscular Research Center

Phoenix, Arizona, United States

Hosp.Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, , Argentina

Instituto de Neurologia de Curitiba - Hospital Ecoville

Curitiba, Paraná, Brazil

University of Alberta Hospital

Edmonton, Alberta, Canada

LHSC - University Hospital

London, Ontario, Canada

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

Medellín, , Colombia

Fakultni nemocnice Ostrava

Ostrava, Poruba, Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Århus Universitetshospital

Aarhus C, , Denmark

CHU de Nice

Nice, Alpes Maritimes, France

Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Bordeaux, Gironde, France

Hopital Neurologique Pierre Wertheimer

Bron, Rhone, France

Universitaetsklinikum Leipzig AoeR

Leipzig, Saxony, Germany

University Hospital of Patra

Pátrai, , Greece

Azienda Ospedaliero Universitaria San Martino

Genova, , Italy

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, , Italy

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Udine, , Italy

Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

Mexico City, Mexico City, Mexico

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, , Poland

Clinical Center of Serbia

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Nis

Niš, , Serbia

Fakultna nemocnica Nitra

Nitra, , Slovakia

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Pamukkale Uni. Med. Fac.

Denizli, , Turkey (Türkiye)

Dokuz Eylul University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

Konya, , Turkey (Türkiye)

Celal Bayar University Medical Faculty

Manisa, , Turkey (Türkiye)

King's College Hospital

London, Greater London, United Kingdom

The Walton Centre

Liverpool, Merseyside, United Kingdom

Countries

United States; Argentina; Brazil; Canada; Colombia; Czechia; Denmark; France; Germany; Greece; Italy; Mexico; Poland; Serbia; Slovakia; Spain; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b5fc54db2bf003ab45c9a

To obtain more information on the study, click here/on this link

Other Identifiers

2016-000374-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

161505

Identifier Type: -

Identifier Source: org_study_id