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

NCT02955355 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-08-28

Study results available
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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

Interventions

BIOLOGICAL

HYQVIA

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

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2023-07-04
Completion
2023-07-04
FDA Drug
Yes

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955355 on ClinicalTrials.gov