Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
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 |
---|---|---|
|
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
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
- 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
- Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population. [13 months]
- Days Out of Work/School/Daycare Due to Infection in the Total ITT Population. [13 months]
- Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population. [13 months]
- Days on Therapeutic Antibiotics in the Total ITT Population. [13 months]
- Days of Unscheduled Visits to Physicians in the Total ITT Population. [13 months]
- Number of Hospitalizations Due to Infection in ITT Population. [13 months]
- Days of Hospitalization Due to Infection in the Total ITT Population. [13 months]
- Yearly Hospitalization Rate Due to Infection in the Total ITT Population. [13 months]
- Yearly Hospitalization Duration Due to Infection in the Total ITT Population. [13 months]
- Distribution of All-cause Hospitalizations in the Total ITT Population. [13 months]
- Duration of All-cause Hospitalizations [13 months]
- Distribution of Fever Episodes in the Total ITT Population. [13 months]
- Duration of Fever Episodes [13 months]
- IgG Trough Levels at Steady State in the Total ITT Population. [13 months]
Eligibility Criteria
Criteria
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.- KB052
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
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
|
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
|
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)
|
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)
|
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)
|
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)
|
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%
|
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)
|
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)
|
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)
|
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%
|
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)
|
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%
|
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)
|
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
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 |
m.calcinai@kedrion.com |
- KB052