Trial Outcomes & Findings for Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD) (NCT NCT00538915)
NCT ID: NCT00538915
Last Updated: 2021-07-30
Results Overview
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
One year
Results posted on
2021-07-30
Participant Flow
First subject enrolled: 24 September 2007. Last subject completed: 24 July 2009. 15 investigative sites, hospital clinics and private physician clinics.
This was an open study. All enrolled subjects received study medication.
Participant milestones
| Measure |
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Each subject received a total Nabi-IGIV 10% \[Immune Globulin Intravenous (Human), 10%\] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Baseline characteristics by cohort
| Measure |
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
n=63 Participants
Each subject received a total Nabi-IGIV 10% \[Immune Globulin Intravenous (Human), 10%\] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: 63 subjects enrolled, received treatment and included in the Safety population. 5 subjects excluded from the Intent To Treat (ITT) population due to significant, excessive protocol violations and an insufficient number of infusions to elicit the intended effect.
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
Outcome measures
| Measure |
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
n=58 Participants
Each subject received a total Nabi-IGIV 10% \[Immune Globulin Intravenous (Human), 10%\] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
|
|---|---|
|
Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment
|
0.035 SBIs Per Total Person-Years
|
Adverse Events
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Serious events: 7 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
n=63 participants at risk
Each subject received a total Nabi-IGIV 10% \[Immune Globulin Intravenous (Human), 10%\] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Infections and infestations
Appendicitis
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Vascular disorders
Hypotension
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Psychiatric disorders
Mental Status Changes
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Infections and infestations
Obstructive Chronic Bronchitis With Acute Exacerbation
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Infections and infestations
Pneumonia Bacterial
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/63 • Number of events 1 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
Other adverse events
| Measure |
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
n=63 participants at risk
Each subject received a total Nabi-IGIV 10% \[Immune Globulin Intravenous (Human), 10%\] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.3%
4/63 • Number of events 4 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
5/63 • Number of events 10 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
General disorders
Fatigue
|
23.8%
15/63 • Number of events 62 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
General disorders
Infusion Site Reaction
|
7.9%
5/63 • Number of events 6 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Infections and infestations
Sinusitis
|
7.9%
5/63 • Number of events 5 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Investigations
Blood Pressure Increased
|
6.3%
4/63 • Number of events 5 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Nervous system disorders
Dizziness
|
6.3%
4/63 • Number of events 4 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Nervous system disorders
Headache
|
42.9%
27/63 • Number of events 147 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
|
Nervous system disorders
Lethargy
|
6.3%
4/63 • Number of events 4 • An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
|
Additional Information
Richard L. Wasserman, M.D., Ph.D.
DallasAllergyImmunology
Phone: (972) 566-7788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60