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NCT04640142 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Primary Immune Deficiency, sponsored by Octapharma.

Active
Registry status
Phase 3
Development phase
50
Enrollment target
20
Study locations

NCT04640142 is a Phase 3 study of Primary Immune Deficiency that is active but no longer recruiting, run by Octapharma. The registered enrollment target is 50 participants, below the 1,195-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT04640142, a Phase 3 study of Primary Immune Deficiency, is active but no longer recruiting, sponsored by Octapharma.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
50 participants
Enrollment target
20
Study locations

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 Studied

Primary Immune Deficiency

Interventions

  • BIOLOGICAL Newnorm

Study Locations (20)

Other

  • Octapharma Research Site - Leipzig
  • Octapharma Research Site - Munich
  • Octapharma Research Site - Budapest
  • Octapharma Research Site - Debrecen
  • Octapharma Research Site - Naples
  • Octapharma Research Site - Roma
  • Octapharma Research Site - Roma
  • Octapharma Research Site - Treviso
  • Octapharma Research Site - Krakow

Florida

  • Octapharma Research Site - Hollywood
  • Octapharma Research Site - Port Saint Lucie
  • Octapharma Research Site - St. Petersburg

California

  • Octapharma Research Site - Irvine

Colorado

  • Octapharma Research Site - Centennial

Illinois

  • Octapharma Research Site - Chicago

Kansas

  • Octapharma Research Site - Overland Park

Kentucky

  • Octapharma Research Site - Louisville

Maryland

  • Octapharma Research Site - White Marsh

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-08-04
Est. Completion 2026-09
Phase Phase 3

Sponsor

Octapharma

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04640142

The ClinicalTrials.gov registry entry for NCT04640142 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,195-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (96% lower). The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Immune Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Newnorm is the first listed.

NCT04640142 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT04640142 about?

NCT04640142 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases". 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

What is the current status of trial NCT04640142?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2021-08-04. Estimated completion is 2026-09.

What conditions does trial NCT04640142 study?

This clinical trial studies the following conditions: Primary Immune Deficiency.

What interventions are being tested in trial NCT04640142?

The interventions under investigation include: Newnorm (BIOLOGICAL).

Who is sponsoring clinical trial NCT04640142?

This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04640142 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.