NCT04640142 is a Phase 3 clinical trial of Newnorm in Primary Immune Deficiency, sponsored by Octapharma.

Who is sponsoring NCT04640142?

NCT04640142 is sponsored by Octapharma.

What drugs are being tested in NCT04640142?

Interventions in NCT04640142: Newnorm.

What condition does NCT04640142 study?

NCT04640142 studies Primary Immune Deficiency.

Is NCT04640142 still recruiting?

NCT04640142 is currently active, enrolled. Last updated 3 June 2026.

Last reviewed 2026-06-03 · How we verify

NCT04640142

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 3 June 2026

What this trial tests

Phase 3 trial testing Newnorm in Primary Immune Deficiency in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 August 2021

Primary endpoint
1 June 2026

1 September 2026

Quick facts

Lead sponsor	Octapharma
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	4 August 2021
Primary completion	1 June 2026
Estimated completion	1 September 2026
Sites	23 locations across United States, Germany, Hungary, Italy, Poland, Slovakia, Ukraine

Drugs / interventions tested

Newnorm — full drug profile →

Conditions studied

Primary Immune Deficiency — all drugs for Primary Immune Deficiency →

Sponsor

Octapharma — full company profile →

Who can join

Adults 2 to 75, any sex, with Primary Immune Deficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Rate of Serious Bacterial Infections
Time frame: 52 weeks
Rate of SBIs (defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment.
Average total IgG concentration
Time frame: 16 weeks
Average total IgG concentration (Cav) on steadystate dosing.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Primary Immune Deficiency

Currently open trials in the same condition.

NCT05321407 — COVID-19 Vaccine Responses in PIDD Subjects · active not recruiting
NCT04459689 — COVID-19 in PID Survey · recruiting
NCT00246857 — Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death · recruiting

Other Octapharma trials

Trials by the same sponsor.

NCT06429787 — Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Antico · recruiting
NCT05523297 — Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery · Phase 3 · completed
NCT04918173 — Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery · Phase 3 · recruiting
NCT04953884 — Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age · Phase 3 · completed
NCT04508530 — Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04640142 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Octapharma
Last refreshed: 3 June 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04640142.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing