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NCT02955355 · ClinicalTrials.gov registry record · Phase 3
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
A Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT02955355: Completed Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Baxalta now part of Shire.
NCT02955355 is a Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy that has completed, run by Baxalta now part of Shire. The registered enrollment target is 85 participants, below the 130-participant average among 4 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02955355, a Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disabili
Conditions Studied
Interventions
- BIOLOGICAL HYQVIA
Study Locations (20)
Other
- Hosp.Britanico de Buenos Aires - Ciudad Autonoma Buenos Aires
- Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA" - Medellín
- Fakultni nemocnice v Motole - Prague
- Århus Universitetshospital - Aarhus C
- University Hospital of Patra - Pátrai
- Azienda Ospedaliero Universitaria San Martino - Genova
- Azienda Ospedaliera Universitaria Policlinico G. Martino - Messina
- Fondazione Istituto Neurologico Casimiro Mondino - Pavia
- Azienda Ospedaliero Universitaria Pisana - Pisa
- Azienda Ospedaliero-Universitaria Santa Maria della Misericordia - Udine
Ontario
- LHSC - University Hospital - London
- Toronto General Hospital, University Health Network - Toronto
Arizona
- Arizona Neuromuscular Research Center - Phoenix
Paraná
- Instituto de Neurologia de Curitiba - Hospital Ecoville - Curitiba
Alberta
- University of Alberta Hospital - Edmonton
Poruba
- Fakultni nemocnice Ostrava - Ostrava
Alpes Maritimes
- CHU de Nice - Nice
Gironde
- Groupe Hospitalier Pellegrin - Hôpital Pellegrin - Bordeaux
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2016-11-14 |
| Est. Completion | 2023-07-04 |
| Phase | Phase 3 |
What the finished NCT02955355 record still lists
NCT02955355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 130-participant average among 4 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy appearing as the primary indexed condition, and to 1 intervention - of which HYQVIA is the first listed.
NCT02955355 names 20 study sites across 10 states, led by Other, Ontario, Arizona.
Frequently Asked Questions
What is clinical trial NCT02955355 about?
NCT02955355 is a clinical study titled "Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP". 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 ...
What is the current status of trial NCT02955355?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2016-11-14. Estimated completion is 2023-07-04.
What conditions does trial NCT02955355 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
What interventions are being tested in trial NCT02955355?
The interventions under investigation include: HYQVIA (BIOLOGICAL).
Who is sponsoring clinical trial NCT02955355?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02955355 being conducted?
This trial has 20 study locations across Arizona, Paraná, Alberta, Ontario, Poruba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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