Trial Outcomes & Findings for Oral Peanut Immunotherapy (NCT NCT01324401)
NCT ID: NCT01324401
Last Updated: 2018-08-08
Results Overview
The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
at least 36 months
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
Control - Crossover
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
|
Peanut OIT
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
26
|
|
Overall Study
COMPLETED
|
3
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Control - Crossover
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
|
Peanut OIT
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
|
|---|---|---|
|
Overall Study
Withdrawn before any treatment
|
0
|
3
|
|
Overall Study
Adverse Event
|
1
|
3
|
Baseline Characteristics
Oral Peanut Immunotherapy
Baseline characteristics by cohort
| Measure |
Control - Crossover
n=4 Participants
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
|
Peanut OIT
n=26 Participants
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
26 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at least 36 monthsThe consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance
Outcome measures
| Measure |
Control - Crossover
n=4 Participants
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
|
Peanut OIT
n=23 Participants
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
|
|---|---|---|
|
Tolerance or Sustained Unresponsiveness
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: at least 36 monthsThe consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment
Outcome measures
| Measure |
Control - Crossover
n=4 Participants
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
|
Peanut OIT
n=23 Participants
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
|
|---|---|---|
|
Desensitization
|
3 Participants
|
19 Participants
|
Adverse Events
Control - Crossover
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Peanut OIT
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control - Crossover
n=4 participants at risk
The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
|
Peanut OIT
n=23 participants at risk
Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
|
|---|---|---|
|
Immune system disorders
Allergy: Skin/Oral pruritis
|
100.0%
4/4 • Number of events 68 • From Oct 2011 to July 2014
|
78.3%
18/23 • Number of events 118 • From Oct 2011 to July 2014
|
|
Immune system disorders
Allergy: Multiple Symptoms
|
100.0%
4/4 • Number of events 18 • From Oct 2011 to July 2014
|
95.7%
22/23 • Number of events 215 • From Oct 2011 to July 2014
|
|
Gastrointestinal disorders
GI: Abdominal Pain
|
100.0%
4/4 • Number of events 39 • From Oct 2011 to July 2014
|
91.3%
21/23 • Number of events 191 • From Oct 2011 to July 2014
|
|
Respiratory, thoracic and mediastinal disorders
Resp: Wheeze/SOB
|
50.0%
2/4 • Number of events 4 • From Oct 2011 to July 2014
|
43.5%
10/23 • Number of events 19 • From Oct 2011 to July 2014
|
Additional Information
Wayne Shreffler
Harvard Medical School / Massachusetts General Hospital
Phone: 617-726-6147
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place