Trial Outcomes & Findings for Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis. (NCT NCT03552393)
NCT ID: NCT03552393
Last Updated: 2022-03-07
Results Overview
The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline up to Week 21
Results posted on
2022-03-07
Participant Flow
The core study was 23 weeks and consisted of three periods: screening (3 weeks), dose titration (16 weeks) and evaluation (4 weeks). Participants completing the 20 weeks of treatment with hemoglobin (Hb) within +/- 1g/dL of their baseline and within the target range of 10-12 g/dL were eligible to enter an optional 24-week safety extension period.
A total of 40 pediatric participants (ages 3 months to 17 years) with a diagnosis of anemia due to chronic kidney disease (CKD) who may or may not have been on dialysis at the time of study start were switched from stable subcutaneous (SC) maintenance treatment with epoetin alfa/beta or darbepoetin to methoxy polyethylene glycol-epoetin beta (Mircera).
Participant milestones
| Measure |
Mircera
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Core Period
STARTED
|
40
|
|
Core Period
COMPLETED
|
38
|
|
Core Period
NOT COMPLETED
|
2
|
|
Safety Extension Period
STARTED
|
25
|
|
Safety Extension Period
COMPLETED
|
21
|
|
Safety Extension Period
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Mircera
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Core Period
Kidney Transplant
|
1
|
|
Core Period
Prohibited Medication
|
1
|
|
Safety Extension Period
Kidney Transplant
|
4
|
Baseline Characteristics
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Baseline characteristics by cohort
| Measure |
Mircera
n=40 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Age, Continuous
|
10.32 years
STANDARD_DEVIATION 5.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 21Population: ITT population included all participants enrolled in the study. Number analyzed is the number of participants with Hb concentration assessment at specified time points.
The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.
Outcome measures
| Measure |
Mircera
n=38 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient
Baseline
|
11.05 grams/deciliter (g/dL)
Standard Deviation 0.51
|
|
Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient
Change at Evaluation Period
|
0.48 grams/deciliter (g/dL)
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Week 17 up to Week 21Population: ITT population included all participants enrolled in the study. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number analyzed is the number of participants with Hb concentration assessment at specified time points.
Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. The evaluation period was defined as the period between Week 17 and Week 21 inclusive.
Outcome measures
| Measure |
Mircera
n=38 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Hb Above 1 g/dL of Baseline
|
15 participants
|
|
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Hb Maintained Within ± 1 g/dL of Baseline
|
19 participants
|
|
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Hb Below 1 g/dL of Baseline
|
4 participants
|
|
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Hb Above 12 g/dL
|
12 participants
|
|
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Hb Maintained Within 10-12 g/dL
|
24 participants
|
|
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Hb Below 10 g/dL
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45Population: ITT population included all participants enrolled in the study. Number analyzed signifies number of participants evaluable at specified time points.
The mean Hb concentration over time and the mean change in Hb from baseline over time are presented.
Outcome measures
| Measure |
Mircera
n=40 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Mean Hb Values and Change From Baseline
Baseline
|
11.02 g/dL
Standard Deviation 0.53
|
|
Mean Hb Values and Change From Baseline
Week 3
|
11.69 g/dL
Standard Deviation 0.97
|
|
Mean Hb Values and Change From Baseline
Change at Week 3
|
0.67 g/dL
Standard Deviation 0.74
|
|
Mean Hb Values and Change From Baseline
Week 5
|
11.21 g/dL
Standard Deviation 1.02
|
|
Mean Hb Values and Change From Baseline
Change at Week 5
|
0.19 g/dL
Standard Deviation 0.94
|
|
Mean Hb Values and Change From Baseline
Week 9
|
11.68 g/dL
Standard Deviation 1.42
|
|
Mean Hb Values and Change From Baseline
Change at Week 9
|
0.64 g/dL
Standard Deviation 1.21
|
|
Mean Hb Values and Change From Baseline
Week 13
|
11.56 g/dL
Standard Deviation 1.17
|
|
Mean Hb Values and Change From Baseline
Change at Week 13
|
0.51 g/dL
Standard Deviation 1.10
|
|
Mean Hb Values and Change From Baseline
Week 17
|
11.46 g/dL
Standard Deviation 1.33
|
|
Mean Hb Values and Change From Baseline
Change at Week 17
|
0.42 g/dL
Standard Deviation 1.39
|
|
Mean Hb Values and Change From Baseline
Week 19
|
11.81 g/dL
Standard Deviation 1.11
|
|
Mean Hb Values and Change From Baseline
Change at Week 19
|
0.77 g/dL
Standard Deviation 1.14
|
|
Mean Hb Values and Change From Baseline
Week 21
|
11.10 g/dL
Standard Deviation 0.91
|
|
Mean Hb Values and Change From Baseline
Change at Week 21
|
0.05 g/dL
Standard Deviation 0.99
|
|
Mean Hb Values and Change From Baseline
Week 25
|
11.29 g/dL
Standard Deviation 1.04
|
|
Mean Hb Values and Change From Baseline
Change at Week 25
|
0.21 g/dL
Standard Deviation 1.12
|
|
Mean Hb Values and Change From Baseline
Week 29
|
11.22 g/dL
Standard Deviation 1.18
|
|
Mean Hb Values and Change From Baseline
Change at Week 29
|
0.15 g/dL
Standard Deviation 1.11
|
|
Mean Hb Values and Change From Baseline
Week 33
|
11.09 g/dL
Standard Deviation 1.11
|
|
Mean Hb Values and Change From Baseline
Change at Week 33
|
0.02 g/dL
Standard Deviation 1.24
|
|
Mean Hb Values and Change From Baseline
Week 37
|
11.04 g/dL
Standard Deviation 0.77
|
|
Mean Hb Values and Change From Baseline
Change at Week 37
|
-0.03 g/dL
Standard Deviation 0.90
|
|
Mean Hb Values and Change From Baseline
Week 41
|
10.83 g/dL
Standard Deviation 0.83
|
|
Mean Hb Values and Change From Baseline
Change at Week 41
|
-0.22 g/dL
Standard Deviation 1.03
|
|
Mean Hb Values and Change From Baseline
Week 45
|
10.68 g/dL
Standard Deviation 1.02
|
|
Mean Hb Values and Change From Baseline
Change at Week 45
|
-0.35 g/dL
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Week 1 to Week 17Population: Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not. Number analyzed signifies number of participants evaluable at specified time points.
A dose change was defined as a change in the administered dose strength compared to the preceding dose.
Outcome measures
| Measure |
Mircera
n=40 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Change in Mircera Dose Over Time
Week 13
|
50.00 micrograms (µg)
Interval 0.0 to 360.0
|
|
Change in Mircera Dose Over Time
Week 1
|
75.00 micrograms (µg)
Interval 15.0 to 360.0
|
|
Change in Mircera Dose Over Time
Week 5
|
75.00 micrograms (µg)
Interval 15.0 to 360.0
|
|
Change in Mircera Dose Over Time
Change at Week 5
|
0.00 micrograms (µg)
Interval -50.0 to 75.0
|
|
Change in Mircera Dose Over Time
Week 9
|
50.00 micrograms (µg)
Interval 0.0 to 360.0
|
|
Change in Mircera Dose Over Time
Change at Week 9
|
0.00 micrograms (µg)
Interval -250.0 to 190.0
|
|
Change in Mircera Dose Over Time
Change at Week 13
|
-25.00 micrograms (µg)
Interval -120.0 to 210.0
|
|
Change in Mircera Dose Over Time
Week 17
|
50.00 micrograms (µg)
Interval 0.0 to 250.0
|
|
Change in Mircera Dose Over Time
Change at Week 17
|
-20.00 micrograms (µg)
Interval -250.0 to 120.0
|
SECONDARY outcome
Timeframe: Week 1, Week 17Population: Participants who received a dose of study drug on Week 1 and Week 17 were included in the analysis.
The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation.
Outcome measures
| Measure |
Mircera
n=33 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17
|
1.44 ratio
Interval 0.2 to 3.8
|
SECONDARY outcome
Timeframe: Baseline up to Week 45Population: Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test.
Outcome measures
| Measure |
Mircera
n=40 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade
Grade 1-2
|
25 participants
|
|
Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade
Grade 3-4
|
8 participants
|
SECONDARY outcome
Timeframe: Pre-dose at Week 1, 9, 17; Post-dose at Week 3, Week 19 and additional sample taken between 24 hours and 5 days at participant's conveniencePopulation: PK population included all participants enrolled in the study.
Bioavailability (F) is defined as the percentage of the administered drug, that reaches the systemic circulation. A population PK model was developed for Mircera that adequately describes pediatric data: a 1-compartment model with first order absorption and elimination processes. The bioavailability (F) was estimated using all the data points listed under time frame using the population PK model.
Outcome measures
| Measure |
Mircera
n=40 Participants
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model
|
67 percentage
|
Adverse Events
Mircera
Serious events: 13 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mircera
n=40 participants at risk
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Congenital, familial and genetic disorders
Hydrocele
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
General disorders
Device related thrombosis
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Device related infection
|
2.5%
1/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Enterovirus infection
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Peritonitis
|
7.5%
3/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Pharyngotonsillitis
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Pyelonephritis
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Rhinovirus infection
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Viral infection
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Product Issues
Device malfunction
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Number of events 1 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
Other adverse events
| Measure |
Mircera
n=40 participants at risk
Mircera was administered subcutaneously once every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
3/40 • Number of events 4 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
General disorders
Injection site pain
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
General disorders
Pyrexia
|
12.5%
5/40 • Number of events 5 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Bronchitis
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Conjunctivitis
|
7.5%
3/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Pharyngitis
|
5.0%
2/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Rhinitis
|
7.5%
3/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
6/40 • Number of events 6 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
12.5%
5/40 • Number of events 5 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Number of events 6 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
2/40 • Number of events 2 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.5%
3/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 3 • Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER