Trial Outcomes & Findings for Intravenous Immunoglobulin (IVIG) in Lung Transplantation (NCT NCT00115778)
NCT ID: NCT00115778
Last Updated: 2019-03-05
Results Overview
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
3 month
Results posted on
2019-03-05
Participant Flow
Eleven subjects were eligible and randomized, and 10 completed all study assessments. One subject discontinued the interventions because of inability to comply with the schedule of study visits. 10 subjects are needed to detect a reduction in the mean number of bacterial infections/patient by one standard deviation over three months with 80% power.
Participant milestones
| Measure |
Group 1: Placebo Then IVIG
Study participants consented to receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of IVIG over 12 weeks (period 2).
Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks)
Analysis: modified intention-to-treat
|
Group: 2 IVIG Then Placebo
Study participants consented to receive three doses of IVIG given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of placebo over 12 weeks (period 2).
Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks)
Analysis: modified intention-to-treat
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Placebo Then IVIG
Study participants consented to receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of IVIG over 12 weeks (period 2).
Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks)
Analysis: modified intention-to-treat
|
Group: 2 IVIG Then Placebo
Study participants consented to receive three doses of IVIG given four weeks apart over 12 weeks (period 1) followed by a twelve-week washout and then three doses of placebo over 12 weeks (period 2).
Period 1 (12 weeks) Washout period (12 weeks) Period 2 (12 weeks)
Analysis: modified intention-to-treat
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Baseline characteristics by cohort
| Measure |
All Participants
n=11 Participants
Study participants consented to receive three doses of IVIG (or 0.1% albumin solution (placebo)) given four weeks apart followed by a twelve-week washout and then three doses of placebo (or IVIG).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthPopulation: The crossover design, in which each subject serves as his or her own control, allows sufficient power for the detection of a clinically significant effect of IVIG with only a small number of patients. A sample size of 10 patients in a crossover trial has more power to detect differences than double the sample size using a parallel design.
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
Outcome measures
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 Participants
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 Participants
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
|
3 Infections
|
1 Infections
|
SECONDARY outcome
Timeframe: 3 monthThis is to measure the effect of IVIG on viral infections.
Outcome measures
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 Participants
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 Participants
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Number of Clinically Diagnosed Viral Infections
|
2 Number of Infections
|
2 Number of Infections
|
SECONDARY outcome
Timeframe: 3 monthThis is to measure the effect of IVIG on hospitalizations.
Outcome measures
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 Participants
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 Participants
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Number of Hospital Admissions
|
3 Admissions
|
1 Admissions
|
SECONDARY outcome
Timeframe: 3 monthThis is to measure the effect of IVIG on the use of antibiotics.
Outcome measures
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 Participants
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 Participants
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Number of Antibiotic Initiation
|
9 Uses of antibiotics
|
8 Uses of antibiotics
|
SECONDARY outcome
Timeframe: 3 monthsThis is to measure the effect of IVIG on fungal infections.
Outcome measures
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 Participants
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 Participants
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Number of Clinically Diagnosed Fungal Infection
|
2 Infections
|
0 Infections
|
SECONDARY outcome
Timeframe: 3 monthsThis is to measure the effect of IVIG on lung function.
Outcome measures
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 Participants
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 Participants
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Number of Lymphocytic Bronchiolitis
|
0 Instances of bronchiolitis
|
0 Instances of bronchiolitis
|
Adverse Events
Participants Receiving IVIG During Period 1 or Period 2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Participants Receiving Placebo During Period 1 or Period 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 participants at risk
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 participants at risk
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
|
Eye disorders
Vitreous hemorrhage
|
10.0%
1/10 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
E. coli pneumonia
|
10.0%
1/10 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
|
Surgical and medical procedures
Hospital admission for thymoglobulin infusion
|
0.00%
0/10 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Participants Receiving IVIG During Period 1 or Period 2
n=10 participants at risk
Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
|
Participants Receiving Placebo During Period 1 or Period 2
n=10 participants at risk
Study participants received three doses of placebo first (Period 1) or second (Period 2 - after a twelve-week washout).
|
|---|---|---|
|
General disorders
Fever
|
20.0%
2/10 • 3 months
|
0.00%
0/10 • 3 months
|
|
General disorders
Night sweats
|
0.00%
0/10 • 3 months
|
20.0%
2/10 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • 3 months
|
10.0%
1/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pedal edema
|
0.00%
0/10 • 3 months
|
30.0%
3/10 • 3 months
|
|
General disorders
Headache
|
20.0%
2/10 • 3 months
|
30.0%
3/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
20.0%
2/10 • 3 months
|
0.00%
0/10 • 3 months
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
1/10 • 3 months
|
20.0%
2/10 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • 3 months
|
20.0%
2/10 • 3 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • 3 months
|
20.0%
2/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
2/10 • 3 months
|
20.0%
2/10 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60