Trial Outcomes & Findings for Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) (NCT NCT00117143)

NCT ID: NCT00117143

Last Updated: 2023-06-26

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

From first dose through 8 weeks after last dose of study drug (11 weeks)

Results posted on

2023-06-26

Participant Flow

This was a multicenter study conducted in 6 centers in France, the Netherlands, and the United Kingdom.

Participants were enrolled sequentially into one of four dose cohorts. When the platelet count of the first participant who received the 500 μg dose increased above 650 × 10⁹ cells/L following the first dose, this cohort was discontinued, and subsequent participants were assigned to the 300 μg cohort.

Participant milestones

Participant milestones
Measure	Romiplostim 30 µg Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Overall Study STARTED	4	4	7	1
Overall Study Received First Dose	4	4	7	1
Overall Study Received Second Dose	4	4	6	0
Overall Study COMPLETED	4	4	7	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Total n=16 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 14.9 • n=5 Participants	37.8 years STANDARD_DEVIATION 13.4 • n=7 Participants	53.9 years STANDARD_DEVIATION 20.4 • n=5 Participants	45.0 years n=4 Participants	50.9 years STANDARD_DEVIATION 17.9 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	15 Participants n=21 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Platelet Count	13.0 10⁹cells/L STANDARD_DEVIATION 6.10 • n=5 Participants	16.5 10⁹cells/L STANDARD_DEVIATION 10.4 • n=7 Participants	16.4 10⁹cells/L STANDARD_DEVIATION 7.77 • n=5 Participants	28.8 10⁹cells/L n=4 Participants	16.3 10⁹cells/L STANDARD_DEVIATION 8.15 • n=21 Participants

PRIMARY outcome

Timeframe: From first dose through 8 weeks after last dose of study drug (11 weeks)

Population: Participants who received at least 1 dose of romiplostim

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Number of Participants With Adverse Events Discontinuations due to adverse events	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Deaths	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events All adverse events	4 Participants	4 Participants	7 Participants	1 Participants
Number of Participants With Adverse Events Serious adverse events	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Adverse Events Treatment-related adverse events	1 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Adverse Events Serious treatment-related adverse events	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Days 29 and 78

Population: Participants who received at least 1 dose of romiplostim

The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Number of Participants With Positive Anti-Romiplostim Antibodies Anti-romiplostim antibodies	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-Romiplostim Antibodies Anti-thrombopoietin antibodies	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)

Population: Participants who received at least 1 dose of romiplostim.

Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Number of Participants Who Achieved a Targeted Therapeutic Platelet Response After First Dose	1 Participants	4 Participants	4 Participants	0 Participants
Number of Participants Who Achieved a Targeted Therapeutic Platelet Response After Second Dose	1 Participants	3 Participants	3 Participants	—
Number of Participants Who Achieved a Targeted Therapeutic Platelet Response After Both Doses	1 Participants	3 Participants	3 Participants	—

SECONDARY outcome

Population: Participants who received at least 1 dose of romiplostim.

Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline After First Dose	2 Participants	4 Participants	5 Participants	1 Participants
Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline After Second Dose	1 Participants	3 Participants	4 Participants	—
Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline After Both Doses	1 Participants	3 Participants	3 Participants	—

SECONDARY outcome

Timeframe: After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Population: Participants who received at least 1 dose of romiplostim.

Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L After First Dose	1 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L After Second Dose	0 Participants	1 Participants	2 Participants	—
Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L After Both Doses	0 Participants	1 Participants	1 Participants	—

SECONDARY outcome

Population: Participants who received at least 1 dose of romiplostim.

Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L After First Dose	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L After Second Dose	0 Participants	0 Participants	0 Participants	—
Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L After Both Doses	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Population: Participants who received at least 1 dose of romiplostim with available data.

Platelet count data after the use of rescue medication were not included.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Change From Baseline to Peak Platelet Level After First Dose	38.75 10⁹ cells/L Standard Deviation 50.50	89.98 10⁹ cells/L Standard Deviation 34.44	271.3 10⁹ cells/L Standard Deviation 558.4	1033.20 10⁹ cells/L Standard Deviation NA Cannot be calculated for 1 participant
Change From Baseline to Peak Platelet Level After Second Dose	11.50 10⁹ cells/L Standard Deviation 14.51	46.48 10⁹ cells/L Standard Deviation 25.15	56.38 10⁹ cells/L Standard Deviation 35.00	—

SECONDARY outcome

Timeframe: From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78

Population: Participants who received at least 1 dose of romiplostim with available data.

Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=4 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 Participants Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Time to Peak Platelet Count After First Dose	10.5 days Interval 8.0 to 11.0	9.0 days Interval 5.0 to 10.0	12.0 days Interval 8.0 to 13.0	17.0 days Interval 17.0 to 17.0
Time to Peak Platelet Count After Second Dose	13.5 days Interval 4.0 to 31.0	9.5 days Interval 8.0 to 12.0	9.0 days Interval 5.0 to 15.0	—

SECONDARY outcome

Timeframe: From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78

Population: Participants who received at least 1 dose of romiplostim with a targeted therapeutic response.

Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included.

Outcome measures

Outcome measures
Measure	Romiplostim 30 µg n=1 Participants Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 Participants Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=4 Participants Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Duration Within the Targeted Therapeutic Range After First Dose	10.0 days Interval 10.0 to 10.0	5.5 days Interval 1.0 to 7.0	8.0 days Interval 5.0 to 15.0	—
Duration Within the Targeted Therapeutic Range After Second Dose	1.0 days Interval 1.0 to 1.0	2.0 days Interval 2.0 to 5.0	8.0 days Interval 1.0 to 49.0	—

Adverse Events

Romiplostim 30 µg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Romiplostim 100 µg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Romiplostim 300 µg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Romiplostim 500 µg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Romiplostim 30 µg n=4 participants at risk Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 100 µg n=4 participants at risk Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 300 µg n=7 participants at risk Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Romiplostim 500 µg n=1 participants at risk Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 1/7 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	100.0% 1/1 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/4 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/7 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	100.0% 1/1 • From first dose through 8 weeks after last dose of study drug (11 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER