A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Recruiting Phase 3 Interventional Study
Chronic Inflammatory Demyelinating Polyneuropathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
161 (estimated)
Sponsor
Kedrion S.p.A. · Industry
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About This Trial

The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged ≥18 years. 2. Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate. …
Contacts

Anna Lotti Suffredini

+39 338 6827568

a.lotti@kedrion.com

CONTACT

Esra Cinar-Jones

+44 7551 563340

e.cinarjones@kedrion.com

CONTACT