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

Sponsor
Kedrion S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01581593
Collaborator
(none)
45
15
1
21.5
3
0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Kedrion IVIG 10%
Phase 3

Detailed Description

People with primary immunodeficiency diseases (PID) have a defective immune system and experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies make up the largest group of PIDs.

The standard care for patients with PID is replacement immunoglobulin (a class of antibodies) solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been shown to increase the time free from serious infection.

Kedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10% will be given by IV infusion to all study participants. The data collected will help determine whether Kedrion IVIG 10% is suitable for treating PID subjects.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).
Actual Study Start Date :
Nov 12, 2012
Actual Primary Completion Date :
Aug 27, 2014
Actual Study Completion Date :
Aug 27, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kedrion IVIG 10%

Kedrion IVIG 10% treatment.

Biological: Kedrion IVIG 10%
Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months

Outcome Measures

Primary Outcome Measures

  1. Incidence of Acute, Serious Bacterial Infections in the Total ITT Population. [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.

Secondary Outcome Measures

  1. Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population. [13 months]

  2. Days Out of Work/School/Daycare Due to Infection in the Total ITT Population. [13 months]

  3. Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population. [13 months]

  4. Days on Therapeutic Antibiotics in the Total ITT Population. [13 months]

  5. Days of Unscheduled Visits to Physicians in the Total ITT Population. [13 months]

  6. Number of Hospitalizations Due to Infection in ITT Population. [13 months]

  7. Days of Hospitalization Due to Infection in the Total ITT Population. [13 months]

  8. Yearly Hospitalization Rate Due to Infection in the Total ITT Population. [13 months]

  9. Yearly Hospitalization Duration Due to Infection in the Total ITT Population. [13 months]

  10. Distribution of All-cause Hospitalizations in the Total ITT Population. [13 months]

  11. Duration of All-cause Hospitalizations [13 months]

  12. Distribution of Fever Episodes in the Total ITT Population. [13 months]

  13. Duration of Fever Episodes [13 months]

  14. IgG Trough Levels at Steady State in the Total ITT Population. [13 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Confirmed clinical diagnosis of a Primary Immunodeficiency Disease

  • Male or female, ages 2 to 70 years

  • Received 300-900 mg/kg of a licensed IVIG therapy at 21 or 28 day intervals for at least 3 months prior to this study

  • 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months (one must be within 6 months) prior to study enrolment

  • Non-pregnant females of child-bearing potential who agree to use adequate birth control during the study

  • Subject is willing to comply with the protocol

  • Authorization to access personal health information.

  • Signed the informed consent form and a child assent form, if appropriate.

  • If currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving Kedrion IVIG 10% and all inclusion and exclusion criteria are satisfied

  • If currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrolment in this study

Exclusion Criteria:
  • Has secondary immunodeficiency.

  • Newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.

  • Has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.

  • Has a history of thrombotic events defined by at least 1 event in subject's lifetime.

  • Has IgA deficiency and is known to have antibodies to IgA.

  • Has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrolment.

  • Has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.

  • Has an acute infection as documented by culture or diagnostic imaging and/or a body temperature exceeding 38.5 °C (101.3 °F) within 7 days prior to screening

  • Has a known history or is positive at enrolment for human immunodeficiency virus (HIV) type 1 by NAT, hepatitis B virus (HBsAg and NAT), hepatitis C virus (by NAT), or hepatitis A virus (by NAT).

  • Has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times of the upper limit of normal for the laboratory designated for the study.

  • Has an implanted venous access device

  • Has profound anemia or persistent severe neutropenia (≤ 1000 neutrophils per mm3)or lymphopenia of less than 500 cells per microliter.

  • Has a severe chronic condition such as renal failure (creatinine concentration > 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g. atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity, or any other condition that the investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.

  • Has a history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to enrolment.

  • Has history of epilepsy or multiple episodes of migraine (defined as at least one episode within 6 months of enrolment) not completely controlled by medication.

  • Is receiving steroids (oral or parenteral daily dose of ≥ 0.15 mg/kg/day of prednisone or equivalent) OR other immunosuppressive drugs or chemotherapy.

  • Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study.

  • Has participated in another clinical study within 3 weeks prior to study enrolment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arkansas Children's Hospital Little Rock Arkansas United States 72202
2 Allergy Associates of the Palm Beaches North Palm Beach Florida United States 33408
3 Family Allergy & Asthma Center, PC Atlanta Georgia United States 30342
4 Rush University Chicago Illinois United States 60612
5 University of Iowa Hospital and Clinics Iowa City Iowa United States 52242
6 Midwest Immunology Clinic Plymouth Minnesota United States 55446
7 AAIR Research Center Rochester New York United States 14618
8 Optimed Research, LTD Columbus Ohio United States 43235
9 Dallas Allergy Immunology Research Dallas Texas United States 75230
10 AARA Research Center Dallas Texas United States 75231
11 Virginia Commonwealth University Health Systems Richmond Virginia United States 23298
12 Marycliff Allergy Specialists Spokane Washington United States 99204
13 Gordon Sussman Clinical Research Inc. Toronto Ontario Canada M4V1R2
14 Pediatric & Adult Allergy & Clinical Immunology Toronto Ontario Canada M5G1E2
15 The Hospital for Sick Children Toronto Ontario Canada M5G1X8

Sponsors and Collaborators

  • Kedrion S.p.A.

Investigators

  • Study Director: Mirella Calcinai, MD, Kedrion SpA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kedrion S.p.A.
ClinicalTrials.gov Identifier:
NCT01581593
Other Study ID Numbers:
  • KB052
First Posted:
Apr 20, 2012
Last Update Posted:
Feb 16, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Kedrion S.p.A.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Infusion Schedule
Arm/Group Description Kedrion IVIG 10% treatment 21 and 28-day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months
Period Title: Overall Study
STARTED 45
COMPLETED 44
NOT COMPLETED 1

Baseline Characteristics

Arm/Group Title Kedrion IVIG 10% 21 and 28 Day Infusion Schedule
Arm/Group Description Kedrion IVIG 10% 21 and 28 Day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Treatment duration - 12 months
Overall Participants 45
Age (Count of Participants)
<=18 years
9
20%
Between 18 and 65 years
27
60%
>=65 years
9
20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
39.9
(20.7)
Sex: Female, Male (Count of Participants)
Female
13
28.9%
Male
32
71.1%

Outcome Measures

1. Primary Outcome
Title Incidence of Acute, Serious Bacterial Infections in the Total ITT Population.
Description 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.
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Infusion Schedule
Arm/Group Description Kedrion IVIG 10% treatment 21 and 28-day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months
Measure Participants 45
Number (99% Confidence Interval) [ASBI's/person-year]
0.04
2. Secondary Outcome
Title Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Infusion Schedule
Arm/Group Description Kedrion IVIG 10% treatment 21 and 28-day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Treatment duration - 12 months
Measure Participants 45
Upper respiratory tract infection
0.42
Sinusitis
0.48
Viral upper respiratory tract infection
0.15
Bronchitis
0.11
Nasopharyngitis
0.11
Rhinitis
0.11
Acute sinusitis
0.15
Gastroenteritis viral
0.09
Herpes zoster
0.11
Urinary tract infection
0.11
3. Secondary Outcome
Title Days Out of Work/School/Daycare Due to Infection in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 & 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [days]
2.8
(6.56)
4. Secondary Outcome
Title Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Infusion Schedule
Arm/Group Description Kedrion IVIG 10% treatment 21 and 28-day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [days]
3.4
(6.53)
5. Secondary Outcome
Title Days on Therapeutic Antibiotics in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Infusion Schedule
Arm/Group Description Kedrion IVIG 10% treatment 21 and 28-day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [days]
23.3
(33.77)
6. Secondary Outcome
Title Days of Unscheduled Visits to Physicians in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Infusion Schedule
Arm/Group Description Kedrion IVIG 10% treatment 21 and 28-day infusion schedule Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [days]
0.9
(1.14)
7. Secondary Outcome
Title Number of Hospitalizations Due to Infection in ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 & 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
0 hospitalizations
42
93.3%
1 hospitalization
2
4.4%
2 hospitalizations
1
2.2%
≥ 3 hospitalizations
0
0%
8. Secondary Outcome
Title Days of Hospitalization Due to Infection in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 & 28 Days Treatments Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [days]
0.6
(2.21)
9. Secondary Outcome
Title Yearly Hospitalization Rate Due to Infection in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 & 28 Days Treatments Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [hospitalizations per year]
0.11
(0.436)
10. Secondary Outcome
Title Yearly Hospitalization Duration Due to Infection in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 & 28 Days Treatments Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [days]
0.55
(2.196)
11. Secondary Outcome
Title Distribution of All-cause Hospitalizations in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
0 hospitalizations
41
91.1%
1 hospitalization
1
2.2%
2 hospitalizations
2
4.4%
3 hospitalizations
1
2.2%
≥ 4 hospitalizations
0
0%
12. Secondary Outcome
Title Duration of All-cause Hospitalizations
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
The duration of the hospitalizations was measured for each of four subjects who were hospitalized and was calculated dividing by the subject's study duration in days.
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 4
Mean (Standard Deviation) [days]
17.8
(12.07)
13. Secondary Outcome
Title Distribution of Fever Episodes in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
0 fever episodes
34
75.6%
1 fever episode
6
13.3%
2 fever episodes
2
4.4%
3 fever episodes
1
2.2%
4 fever episodes
1
2.2%
5 fever episodes
1
2.2%
14. Secondary Outcome
Title Duration of Fever Episodes
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
The duration of fever episodes was measured for each of eleven subjects who experienced this event.
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 11
Mean (Standard Deviation) [days]
6.5
(4.87)
15. Secondary Outcome
Title IgG Trough Levels at Steady State in the Total ITT Population.
Description
Time Frame 13 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Kedrion IVIG 10% 21 and 28 Days Treatment Schedule
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Measure Participants 45
Mean (Standard Deviation) [mg/dL]
888
(197)

Adverse Events

Time Frame 13 months
Adverse Event Reporting Description
Arm/Group Title Kedrion IVIG 10%
Arm/Group Description Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Duration - 12 months
All Cause Mortality
Kedrion IVIG 10%
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
Kedrion IVIG 10%
Affected / at Risk (%) # Events
Total 4/45 (8.9%)
Gastrointestinal disorders
Diarrhoea 1/45 (2.2%) 1
Infections and infestations
Bacterial pneumonia 1/45 (2.2%) 1
Herpes zoster 1/45 (2.2%) 1
Infective exacerbation of bronchiectasis 1/45 (2.2%) 1
Pneumonia 1/45 (2.2%) 1
Injury, poisoning and procedural complications
Humerus Fracture 1/45 (2.2%) 1
Psychiatric disorders
Bipolar disorder 1/45 (2.2%) 2
Other (Not Including Serious) Adverse Events
Kedrion IVIG 10%
Affected / at Risk (%) # Events
Total 44/45 (97.8%)
Blood and lymphatic system disorders
Lymphadenopathy 3/45 (6.7%) 3
Eye disorders
Eye Disorders 4/45 (8.9%) 6
Gastrointestinal disorders
Diarrhoea 8/45 (17.8%) 12
Nausea 4/45 (8.9%) 7
Vomiting 4/45 (8.9%) 5
General disorders
Pyrexia 11/45 (24.4%) 22
Fatigue 8/45 (17.8%) 11
Adverse drug reaction 3/45 (6.7%) 3
Immune system disorders
Immune System Disorders 3/45 (6.7%) 4
Infections and infestations
Upper Respiratory Tract Infection 13/45 (28.9%) 18
Sinusitis 11/45 (24.4%) 22
Viral Upper Respiratory Infection 5/45 (11.1%) 7
Rhinitis 4/45 (8.9%) 5
Acute Sinusitis 3/45 (6.7%) 6
Bronchitis 3/45 (6.7%) 3
Gastroenteritis Viral 3/45 (6.7%) 4
Nasopharyngitis 3/45 (6.7%) 4
Urinary Tract Infection 3/45 (6.7%) 5
Injury, poisoning and procedural complications
Contusion 3/45 (6.7%) 3
Investigations
Investigations 12/45 (26.7%) 21
Metabolism and nutrition disorders
Metabolism and nutrition disorders 4/45 (8.9%) 5
Musculoskeletal and connective tissue disorders
Back Pain 7/45 (15.6%) 8
Myalgia 3/45 (6.7%) 6
Arthralgia 3/45 (6.7%) 4
Pain in extremity 3/45 (6.7%) 3
Nervous system disorders
Headache 12/45 (26.7%) 21
Sinus Headache 4/45 (8.9%) 5
Psychiatric disorders
Insomnia 4/45 (8.9%) 4
Respiratory, thoracic and mediastinal disorders
Cough 10/45 (22.2%) 19
Oropharyngeal Pain 5/45 (11.1%) 9
Asthma 5/45 (11.1%) 5
Nasal Congestion 4/45 (8.9%) 6
Rhinorrhoea 3/45 (6.7%) 7
Sneezing 3/45 (6.7%) 3
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders 6/45 (13.3%) 18
Vascular disorders
Vascular Disorders 3/45 (6.7%) 5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Mirella Calcinai, MD, Clinical Research Director
Organization Kedrion S.p.A
Phone +393486559761
Email m.calcinai@kedrion.com
Responsible Party:
Kedrion S.p.A.
ClinicalTrials.gov Identifier:
NCT01581593
Other Study ID Numbers:
  • KB052
First Posted:
Apr 20, 2012
Last Update Posted:
Feb 16, 2021
Last Verified:
Jan 1, 2021