Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure. (NCT NCT00474955)
NCT ID: NCT00474955
Last Updated: 2016-07-25
Results Overview
Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (\<50 international units \[IU\]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
At Week 72
Results posted on
2016-07-25
Participant Flow
A total of 27 participants were enrolled in this study conducted from 2006 to 2011 at 5 centers in Russian Federation.
Participant milestones
| Measure |
Peginterferon Alpha-2a
Eligible participants were administered peginterferon alpha-2a \[Pegasys\] \[40 kilo Dalton (kDa)\], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of \<15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Overall Study
STARTED
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27
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Peginterferon Alpha-2a
Eligible participants were administered peginterferon alpha-2a \[Pegasys\] \[40 kilo Dalton (kDa)\], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of \<15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Drug unavailability
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1
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Overall Study
Personal reasons
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5
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Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Baseline characteristics by cohort
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Age, Continuous
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44 years
STANDARD_DEVIATION 11 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At Week 72Population: ITT population included all enrolled participants who received at least one dose of study medication.
Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (\<50 international units \[IU\]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
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55.6 Percentage of participants
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PRIMARY outcome
Timeframe: At Week 24 and Week 48Population: ITT population included all enrolled participants who received at least one dose of study medication.
HCV RNA level less than 50 IU/mL was considered to be undetectable.
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
At Week 24
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59.3 Percentage of participants
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Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
At Week 48
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48.1 Percentage of participants
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PRIMARY outcome
Timeframe: From Baseline (Days -30 to -1) and Week 24Population: ITT population included all enrolled participants who received at least one dose of study medication.
The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit \[Days -30 to -1\]).
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline
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33.3 Percentage of participants
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SECONDARY outcome
Timeframe: Up to Week 72Population: Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Participants with any AEs
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10 Participants
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Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Participants with any SAEs
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2 Participants
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SECONDARY outcome
Timeframe: Up to Week 48Population: ITT population included all enrolled participants who received at least one dose of study medication.
Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
Personal reasons (not related to the study)
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5 Participants
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Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
Adverse events
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2 Participants
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Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
Drug unavailability
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1 Participants
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SECONDARY outcome
Timeframe: Up to Week 72Population: ITT population included all enrolled participants who received at least one dose of study medication.
Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit \[Days -30 to -1\]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
ALP Increased Baseline
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7 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
ALP Increased, V3
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9 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Ferritin Increased, Baseline
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18 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Increased, Baseline
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7 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, Baseline
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6 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V1
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5 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V2
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4 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V3
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4 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V4
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6 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V5
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8 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V6
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5 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V7
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2 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V8
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4 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V9
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3 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGPT Increased, V10
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3 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGOT Increased, Baseline
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4 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
SGOT Increased, V3
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2 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
GGTP Increased, V3
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1 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Total bilirubin Increased, Baseline
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1 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Ferritin Decreased, Baseline
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1 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Ferritin Increased, V1
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18 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Ferritin Increased, V4
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17 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Ferritin Increased, V5
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14 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Ferritin Increased, V7
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14 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Decreased, Baseline
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2 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Increased, V1
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8 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Decreased, V1
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1 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Increased, V4
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7 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Increased, V5
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4 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Decreased, V5
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1 Participants
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Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Transferrin saturation Increased, V7
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7 Participants
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SECONDARY outcome
Timeframe: From Baseline (Days -30 to -1) to Week 72Population: ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by 'n'.
Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit \[Days -30 to -1\]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V2, n=27
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-0.7 Millimeter (mm) of Mercury
Standard Deviation 8.6
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V3, n=27
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0.6 Millimeter (mm) of Mercury
Standard Deviation 12.1
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V4, n=26
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-2.9 Millimeter (mm) of Mercury
Standard Deviation 7.2
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V5, n=23
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-1.3 Millimeter (mm) of Mercury
Standard Deviation 10.1
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V6, n=23
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-2.6 Millimeter (mm) of Mercury
Standard Deviation 9.0
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V7, n=19
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-3.7 Millimeter (mm) of Mercury
Standard Deviation 9.6
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V8, n=27
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-4.6 Millimeter (mm) of Mercury
Standard Deviation 8.1
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V9, n=21
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-3.6 Millimeter (mm) of Mercury
Standard Deviation 9.1
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Mean Change From Baseline in Blood Pressure up to Week 72
DBP, V10, n=21
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-3.8 Millimeter (mm) of Mercury
Standard Deviation 9.2
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V2, n=27
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-2.8 Millimeter (mm) of Mercury
Standard Deviation 12.9
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V3, n=27
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1.3 Millimeter (mm) of Mercury
Standard Deviation 15.6
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V4, n=26
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-4.0 Millimeter (mm) of Mercury
Standard Deviation 11.6
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V5, n=23
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-0.7 Millimeter (mm) of Mercury
Standard Deviation 12.0
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V6, n=23
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-0.4 Millimeter (mm) of Mercury
Standard Deviation 10.3
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V7, n=19
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-4.2 Millimeter (mm) of Mercury
Standard Deviation 13.2
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V8, n=27
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-5.2 Millimeter (mm) of Mercury
Standard Deviation 11.3
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V9, n=21
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-3.1 Millimeter (mm) of Mercury
Standard Deviation 17.4
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Mean Change From Baseline in Blood Pressure up to Week 72
SBP, V10, n=21
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-4.5 Millimeter (mm) of Mercury
Standard Deviation 14.7
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SECONDARY outcome
Timeframe: From Baseline (Days -30 to -1) to Week 72Population: ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by 'n'.
Mean change from baseline in heart rate was recorded at Baseline (Screening visit \[Days -30 to -1\]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Outcome measures
| Measure |
Peginterferon Alpha-2a
n=27 Participants
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
|
|---|---|
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Mean Change From Baseline in Heart Rate up to Week 72
V5, n=23
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1.1 Beats per minute (bpm)
Standard Deviation 5.6
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Mean Change From Baseline in Heart Rate up to Week 72
V6, n=23
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0.5 Beats per minute (bpm)
Standard Deviation 6.0
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Mean Change From Baseline in Heart Rate up to Week 72
V2, n=27
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0.7 Beats per minute (bpm)
Standard Deviation 4.9
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Mean Change From Baseline in Heart Rate up to Week 72
V3, n=27
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1.5 Beats per minute (bpm)
Standard Deviation 4.2
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Mean Change From Baseline in Heart Rate up to Week 72
V4, n=26
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2.6 Beats per minute (bpm)
Standard Deviation 7.9
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|
Mean Change From Baseline in Heart Rate up to Week 72
V7, n=19
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1.3 Beats per minute (bpm)
Standard Deviation 6.4
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|
Mean Change From Baseline in Heart Rate up to Week 72
V8, n=27
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2.0 Beats per minute (bpm)
Standard Deviation 5.2
|
|
Mean Change From Baseline in Heart Rate up to Week 72
V9, n=21
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1.4 Beats per minute (bpm)
Standard Deviation 3.1
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Mean Change From Baseline in Heart Rate up to Week 72
V10, n=21
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-0.2 Beats per minute (bpm)
Standard Deviation 4.4
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Adverse Events
Peginterferon Alpha-2a
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon Alpha-2a
n=27 participants at risk
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
1/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Injury, poisoning and procedural complications
Right acromioclavicular joint dislocation
|
3.7%
1/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
Other adverse events
| Measure |
Peginterferon Alpha-2a
n=27 participants at risk
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of \<15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
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|---|---|
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Blood and lymphatic system disorders
Neutropenia
|
7.4%
2/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.4%
2/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
4/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.7%
1/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
3.7%
1/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
|
|
Skin and subcutaneous tissue disorders
Weber-Christian disease
|
3.7%
1/27 • Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
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Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
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