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Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
NCT02955355 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02955355
The ClinicalTrials.gov registry entry for NCT02955355 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02955355 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Ontario, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02955355?
The interventions under investigation include: HYQVIA (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02955355?
This trial is sponsored by Baxalta now part of Shire, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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