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Study of PlasmaCap IG in Adults and Children With PIDD

NCT03238079 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-05-07

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North America for the treatment of subjects with primary immune deficiency diseases (PIDD).

Conditions

  • Primary Immune Deficiency Diseases (PIDD)

Interventions

BIOLOGICAL

10% IGIV

300-900 mg/kg

Sponsors & Collaborators

  • Therapure Biopharma Inc

    lead INDUSTRY

Principal Investigators

  • Mark Krause · Therapure Biopharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2020-08-25
Completion
2020-12-30
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT03238079 on ClinicalTrials.gov