Have you or your loved ones been diagnosed with Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?

You may be eligible to participate in a Pediatric CIDP clinical trial.

Have you or your loved ones been diagnosed with Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)? You may be eligible to participate in a Pediatric CIDP clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Clinical Trial

NCT03684018 | Phase 4 | Interventional

Have you or your loved ones been diagnosed with Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?

You may be eligible to participate in a Pediatric CIDP clinical trial.

Have you or your loved ones been diagnosed with Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)? You may be eligible to participate in a Pediatric CIDP clinical trial.

Recruiting

Male & Female

2 - 17

Years old

This study is looking to recruit 30 Participants

A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment

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Details for the study

Brief Title

Two Dose Levels of Privigen in Pediatric CIDP

Official Title

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

Brief Summary

Treatments and/or Procedures

Ig pro 10

Normal human immunoglobulin G administered intravenously

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level

CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase

Approximately 24 weeks

Secondary

Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level

CIDP recovery in the Randomized Phase, defined as decrease in mRS score as comparedto baseline AND mRS score of 1 or 0 at end of Randomized Phase

Approximately 24 weeks

Secondary

Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level

CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline

Approximately 24 weeks

Secondary

Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level

CIDP recovery in the Dose Exploration Phase, defined as decrease in mRS score compared to baseline AND mRS score of 1 or 0 at end of DEP

Approximately 24 weeks

Secondary

Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase

The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)

Baseline and Approximately 24 weeks

Secondary

Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level

CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit

Approximately 24 weeks

Study Criteria

Inclusion Criteria:

  -  Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.

Exclusion Criteria:

  -  Absence of CIDP symptoms

  -  History or family history of inherited neuropathy

  -  Diagnosed developmental delay or regression

  -  History of thrombotic episode

  -  Known or suspected hypersensitivity to Privigen

  -  Known allergic or other severe reactions to blood products

  -  Female subject of childbearing potential either not using or not willing to use a
     medically reliable method of contraception or not sexually abstinent during the study

  -  Pregnant or breastfeeding mother"