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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 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.

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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.

Conditions Studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

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

FieldValue
Enrollment Target 85 participants
Start Date 2016-11-14
Est. Completion 2023-07-04
Phase Phase 3

Sponsor

Baxalta now part of Shire

74 total trials

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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, categorized as Phase 3. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 4 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy trials with a reported enrollment target (35% lower). The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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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