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Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases

NCT04640142 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-03

No results posted yet for this study

Summary

Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases

Conditions

  • Primary Immune Deficiency

Interventions

BIOLOGICAL

Newnorm

Newnorm is a 20% human normal immunoglobulin for SC infusion.

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Hungary
  • Italy
  • Poland
  • Slovakia
  • Ukraine

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 NCT04640142 on ClinicalTrials.gov