NCT01581593 is a Phase 3 clinical trial of Kedrion IVIG 10% in Primary Immunodeficiency, sponsored by Kedrion S.p.A..

Who is sponsoring NCT01581593?

NCT01581593 is sponsored by Kedrion S.p.A..

What drugs are being tested in NCT01581593?

Interventions in NCT01581593: Kedrion IVIG 10%.

What condition does NCT01581593 study?

NCT01581593 studies Primary Immunodeficiency, Agammaglobulinemia, Hypogammaglobulinemia, Antibody Deficiency.

Is NCT01581593 still recruiting?

NCT01581593 is currently completed. Last updated 16 February 2021.

Are results published for NCT01581593?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-02-16 · How we verify

NCT01581593

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

Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

Completed Phase 3 Results posted Last updated 16 February 2021

What this trial tests

Phase 3 trial testing Kedrion IVIG 10% in Primary Immunodeficiency in 45 participants. Completed in 27 August 2014.

Timeline

12 November 2012

Primary endpoint
27 August 2014

27 August 2014

Quick facts

Lead sponsor	Kedrion S.p.A.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	12 November 2012
Primary completion	27 August 2014
Estimated completion	27 August 2014
Sites	15 locations across Canada, United States

Drugs / interventions tested

Kedrion IVIG 10% — full drug profile →

Conditions studied

Primary Immunodeficiency — all drugs for Primary Immunodeficiency →
Agammaglobulinemia — all drugs for Agammaglobulinemia →
Hypogammaglobulinemia — all drugs for Hypogammaglobulinemia →
Antibody Deficiency — all drugs for Antibody Deficiency →

Sponsor

Kedrion S.p.A. — full company profile →

Who can join

Adults 2 to 70, any sex, with Primary Immunodeficiency or Agammaglobulinemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Acute, Serious Bacterial Infections in the Total ITT Population. Primary · 13 months

The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis, meeting EMA and FDA criteria.

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.04	0.00 – 0.11

Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population. Secondary · 13 months

Upper respiratory tract infection

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.42

Sinusitis

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.48

Viral upper respiratory tract infection

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.15

Bronchitis

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.11

Nasopharyngitis

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.11

Rhinitis

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.11

Acute sinusitis

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.15

Gastroenteritis viral

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.09

Days Out of Work/School/Daycare Due to Infection in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatment Schedule	2.8	± 6.56

Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	3.4	± 6.53

Days on Therapeutic Antibiotics in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	23.3	± 33.77

Days of Unscheduled Visits to Physicians in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Infusion Schedule	0.9	± 1.14

Number of Hospitalizations Due to Infection in ITT Population. Secondary · 13 months

0 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatment Schedule	42

1 hospitalization

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatment Schedule	2

2 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatment Schedule	1

≥ 3 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatment Schedule	0

Days of Hospitalization Due to Infection in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatments Schedule	0.6	± 2.21

Yearly Hospitalization Rate Due to Infection in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatments Schedule	0.11	± 0.436

Yearly Hospitalization Duration Due to Infection in the Total ITT Population. Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 & 28 Days Treatments Schedule	0.55	± 2.196

Distribution of All-cause Hospitalizations in the Total ITT Population. Secondary · 13 months

0 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Treatment Schedule	41

1 hospitalization

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Treatment Schedule	1

2 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Treatment Schedule	2

3 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Treatment Schedule	1

≥ 4 hospitalizations

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Treatment Schedule	0

Duration of All-cause Hospitalizations Secondary · 13 months

Group	Value	95% CI
Kedrion IVIG 10% 21 and 28 Days Treatment Schedule	17.8	± 12.07

Adverse events — posted to ClinicalTrials.gov

Time frame: 13 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Kedrion IVIG 10%

Serious: 4/45 (9%)

Deaths: —

Serious adverse events (7 terms)

Reaction	System	Kedrion IVIG 10%
Bacterial pneumonia	Infections and infestations	—
Herpes zoster	Infections and infestations	—
Infective exacerbation of bronchiectasis	Infections and infestations	—
Bipolar disorder	Psychiatric disorders	—
Diarrhoea	Gastrointestinal disorders	—
Humerus Fracture	Injury, poisoning and procedural complications	—
Pneumonia	Infections and infestations	—

Other adverse events (36 terms — click to expand)

Reaction	System	Kedrion IVIG 10%
Upper Respiratory Tract Infection	Infections and infestations	—
Headache	Nervous system disorders	—
Investigations	Investigations	—
Sinusitis	Infections and infestations	—
Pyrexia	General disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Fatigue	General disorders	—
Diarrhoea	Gastrointestinal disorders	—
Back Pain	Musculoskeletal and connective tissue disorders	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—
Viral Upper Respiratory Infection	Infections and infestations	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Rhinitis	Infections and infestations	—
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	—
Sinus Headache	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Insomnia	Psychiatric disorders	—
Eye Disorders	Eye disorders	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—
Acute Sinusitis	Infections and infestations	—
Bronchitis	Infections and infestations	—
Gastroenteritis Viral	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Urinary Tract Infection	Infections and infestations	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—
Adverse drug reaction	General disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Contusion	Injury, poisoning and procedural complications	—
Lymphadenopathy	Blood and lymphatic system disorders	—
Immune System Disorders	Immune system disorders	—
Vascular Disorders	Vascular disorders	—

Most-reported serious reactions: Bacterial pneumonia, Herpes zoster, Infective exacerbation of bronchiectasis, Bipolar disorder, Diarrhoea, Humerus Fracture, Pneumonia.

Data from ClinicalTrials.gov NCT01581593 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Kedrion IVIG 10%

Trials testing the same drug.

NCT04944979 — Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10) · Phase 3 · active not recruiting
NCT03961009 — Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients · Phase 3 · completed

Other recruiting trials for Primary Immunodeficiency

Currently open trials in the same condition.

NCT07076446 — An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 i · Phase 4 · recruiting
NCT06092528 — Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency · NA · recruiting
NCT04864886 — Metabolic Profiling of Immune Responses in Immune-mediated Diseases · recruiting
NCT03610802 — Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies · recruiting
NCT03206099 — NIAID Centralized Sequencing Protocol · recruiting

Other Kedrion S.p.A. trials

Trials by the same sponsor.

NCT04944979 — Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10) · Phase 3 · active not recruiting
NCT03961009 — Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients · Phase 3 · completed
NCT01531803 — Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients · Phase 4 · terminated
NCT01554956 — Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients · Phase 2, PHASE3 · completed
NCT04586062 — Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population · available

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 NCT01581593 (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 Kedrion S.p.A.
Last refreshed: 16 February 2021

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/NCT01581593.

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