Trial Outcomes & Findings for A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) (NCT NCT00912093)

NCT ID: NCT00912093

Last Updated: 2021-06-11

Results Overview

Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

Up to 120 hours post-dose

Results posted on

2021-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized-Icatibant (Blinded Treatment)-Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase	Randomized-Icatibant (Blinded Treatment)-Laryngeal Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Laryngeal Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase	Open-Label Icatibant-Severe Laryngeal Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
The Controlled Phase STARTED	43	45	3	2	5
The Controlled Phase COMPLETED	43	43	3	2	4
The Controlled Phase NOT COMPLETED	0	2	0	0	1
The Open Label Extension (OLE) Phase STARTED	38	35	3	2	4
The Open Label Extension (OLE) Phase COMPLETED	38	35	3	2	4
The Open Label Extension (OLE) Phase NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized-Placebo (Blinded Treatment)-Non-laryngeal Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase	Open-Label Icatibant-Severe Laryngeal Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
The Controlled Phase Death	1	0
The Controlled Phase Medical Condition	1	0
The Controlled Phase Lost to Follow-up	0	1

Baseline Characteristics

A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized-Icatibant (Blinded Treatment)--Non-laryngeal n=43 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal n=45 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase	Randomized-Icatibant (Blinded Treatment)--Laryngeal n=3 Participants Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Laryngeal n=2 Participants Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase	Open-Label Icatibant-Severe Laryngeal n=5 Participants Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase	Total n=98 Participants Total of all reporting groups
Age, Continuous	36.1 years STANDARD_DEVIATION 13.69 • n=5 Participants	36.6 years STANDARD_DEVIATION 11.18 • n=7 Participants	40.3 years STANDARD_DEVIATION 6.66 • n=5 Participants	50.0 years STANDARD_DEVIATION 22.63 • n=4 Participants	41.6 years STANDARD_DEVIATION 11.78 • n=21 Participants	37.0 years STANDARD_DEVIATION 12.46 • n=10 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	29 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	61 Participants n=10 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	37 Participants n=10 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	40 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	87 Participants n=10 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants
Region of Enrollment United States	26 Participants n=5 Participants	32 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	65 Participants n=10 Participants
Region of Enrollment Hungary	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Region of Enrollment Ukraine	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Region of Enrollment Romania	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants
Region of Enrollment Australia	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants
Region of Enrollment Russian Federation	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Region of Enrollment South Africa	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants
Region of Enrollment Israel	4 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	10 Participants n=10 Participants
Weight (kg) <= 50 kg	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants
Weight (kg) >50-75 kg	16 Participants n=5 Participants	20 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	39 Participants n=10 Participants
Weight (kg) >75-100 kg	14 Participants n=5 Participants	13 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	31 Participants n=10 Participants
Weight (kg) >100 kg	9 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	22 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 120 hours post-dose

Population: Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.

Outcome measures

Outcome measures
Measure	Randomized-Icatibant (Blinded Treatment)--Non-laryngeal n=43 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal n=45 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient	2.0 Hours Interval 1.5 to 3.0	19.8 Hours Interval 6.1 to 26.3

SECONDARY outcome

Timeframe: Up to 120 hours post-dose

Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.

Outcome measures

Outcome measures
Measure	Randomized-Icatibant (Blinded Treatment)--Non-laryngeal n=43 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal n=45 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Time to Onset of Primary Symptom Relief	1.5 Hours Interval 1.0 to 2.0	18.5 Hours Interval 3.6 to 23.9

SECONDARY outcome

Timeframe: Up to 120 Hours post treatment

Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores \<10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.

Outcome measures

Outcome measures
Measure	Randomized-Icatibant (Blinded Treatment)--Non-laryngeal n=43 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal n=45 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Time to Almost Complete Symptom Relief	8.0 Hours Interval 5.0 to 42.5	36.0 Hours Interval 29.0 to 50.9

SECONDARY outcome

Timeframe: Up to 120 hours post-dose

Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.

Outcome measures

Outcome measures
Measure	Randomized-Icatibant (Blinded Treatment)--Non-laryngeal n=43 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal n=45 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Time to Subject-Assessed Initial Symptom Improvement	0.8 Hours Interval 0.5 to 1.0	3.5 Hours Interval 1.9 to 5.4

SECONDARY outcome

Timeframe: Up to 120 hours post-dose

Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.

Outcome measures

Outcome measures
Measure	Randomized-Icatibant (Blinded Treatment)--Non-laryngeal n=43 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase	Randomized-Placebo (Blinded Treatment)-Non-laryngeal n=45 Participants Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
Time to Investigator-Assessed Initial Symptom Improvement	0.8 Hours Interval 0.6 to 1.3	3.4 Hours Interval 2.6 to 6.0

Adverse Events

Controlled Phase - Icatibant (Randomized)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Controlled Phase -Placebo (Randomized)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Controlled Phase - Icatibant (Open Label)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open Label Extension - Icatibant (Open Label)

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Controlled Phase - Icatibant (Randomized) n=46 participants at risk Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase	Controlled Phase -Placebo (Randomized) n=46 participants at risk Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase	Controlled Phase - Icatibant (Open Label) n=6 participants at risk Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase	Open Label Extension - Icatibant (Open Label) n=82 participants at risk Subjects who treated with icatibant 30 mg in the open label extension phase
Cardiac disorders Myocardial infarction	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	2.2% 1/46 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/82 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Congenital, familial and genetic disorders Hereditary angioedema	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	4.3% 2/46 • Number of events 2 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	3.7% 3/82 • Number of events 3 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Infections and infestations Gastroenteritis	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	2.2% 1/46 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/82 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Surgical and medical procedures Tracheostomy	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	2.2% 1/46 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/82 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Cardiac disorders Arrhythmia	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	1.2% 1/82 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
General disorders Non-Cardiac Chest Pain	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	1.2% 1/82 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	1.2% 1/82 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	1.2% 1/82 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Hepatobiliary disorders Cholecystitis	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	1.2% 1/82 • Number of events 1 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received

Other adverse events

Other adverse events
Measure	Controlled Phase - Icatibant (Randomized) n=46 participants at risk Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase	Controlled Phase -Placebo (Randomized) n=46 participants at risk Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase	Controlled Phase - Icatibant (Open Label) n=6 participants at risk Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase	Open Label Extension - Icatibant (Open Label) n=82 participants at risk Subjects who treated with icatibant 30 mg in the open label extension phase
Congenital, familial and genetic disorders Hereditary angioedema	10.9% 5/46 • Number of events 5 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	19.6% 9/46 • Number of events 9 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	13.4% 11/82 • Number of events 17 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Nervous system disorders Headache	6.5% 3/46 • Number of events 4 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	6.5% 3/46 • Number of events 3 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	11.0% 9/82 • Number of events 12 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/46 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	0.00% 0/6 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received	6.1% 5/82 • Number of events 7 • Treatment emergent adverse events occurring within 16 days of study drug administration are included in the analysis Subjects were analyzed according to the treatment actual received

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Shire's agreements with investigators vary. All agreements provide Shire the right to embargo communications regarding trial results prior to public release for a period ≤180 days from the time submitted to Shire for review. Shire does not prohibit publication, but can require the removal of confidential information (excluding trial results) and can request postponement of a single-center publication until after disclosure of the trial's multi-center publication.
Publication restrictions are in place

Restriction type: OTHER