Trial Outcomes & Findings for A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105) (NCT NCT01667107)
NCT ID: NCT01667107
Last Updated: 2018-10-09
Results Overview
Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Cystic Fibrosis Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
18
|
|
Overall Study
COMPLETED
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Cystic Fibrosis Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Tolerability issues
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
Baseline characteristics by cohort
| Measure |
Cystic Fibrosis Participants
n=8 Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=18 Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Total
n=26 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
30.0 Years
STANDARD_DEVIATION 7.82 • n=93 Participants
|
52.4 Years
STANDARD_DEVIATION 10.39 • n=4 Participants
|
45.5 Years
STANDARD_DEVIATION 14.22 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43Population: The population to be analyzed included participants who complied with the protocol sufficiently to ensure that the results would exhibit the effects of treatment
Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 42Population: The population analyzed included all enrolled participants who had BAL and serum samples collected at the time of bronchoscopy and analyzed for posaconazole concentration. A participant could have more than 1 pair of samples (BAL and serum) included in the analysis.
Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.
Outcome measures
| Measure |
Cystic Fibrosis Participants
n=9 paired BAL and serum samples
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=11 paired BAL and serum samples
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
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|---|---|---|
|
Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum
BAL
|
1.116 mg/L
Standard Deviation 1.1699
|
0.764 mg/L
Standard Deviation 0.800
|
|
Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum
Serum
|
0.829 mg/L
Standard Deviation 0.3742
|
0.7488 mg/L
Standard Deviation 0.3131
|
SECONDARY outcome
Timeframe: Up to Day 84Population: Participants were analyzed according to the group in which they were enrolled
Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.
Outcome measures
| Measure |
Cystic Fibrosis Participants
n=8 Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=18 Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Percentage of Participants Who Develop Invasive Fungal Infection
|
12.5 Percentage of participants
Interval 2.2 to 47.1
|
16.7 Percentage of participants
Interval 5.8 to 39.2
|
POST_HOC outcome
Timeframe: Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43Population: The population analyzed included all enrolled participants who reached and maintained posaconazole concentration of \>=0.5 mg/L
Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. A posaconazole concentration \>=0.5 mg/L is the therapeutic level, the concentration thought to lead to antifungal efficacy. The time at which the serum posaconazole concentration reached \>=0.5 mg/mL and remained at that level for all subsequent assessments was recorded.
Outcome measures
| Measure |
Cystic Fibrosis Participants
n=6 Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=14 Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L
|
12.2 Days
Standard Deviation 8.82
|
11.9 Days
Standard Deviation 9.86
|
POST_HOC outcome
Timeframe: Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43Population: The population analyzed included all enrolled participants
Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The maximum serum concentration of posaconazole was recorded.
Outcome measures
| Measure |
Cystic Fibrosis Participants
n=8 Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=18 Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Maximum Serum Concentration of Posaconazole (Cmax)
|
1.481 mg/L
Standard Deviation 0.6014
|
1.539 mg/L
Standard Deviation 0.8471
|
POST_HOC outcome
Timeframe: Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43Population: The population analyzed included all enrolled participants
Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time required to achieve the maximum serum concentration of posaconazole was recorded.
Outcome measures
| Measure |
Cystic Fibrosis Participants
n=8 Participants
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=18 Participants
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Time to Maximum Serum Concentration of Posaconazole (Tmax)
|
19.5 Days
Standard Deviation 12.39
|
23.1 Days
Standard Deviation 13.73
|
Adverse Events
Cystic Fibrosis Participants
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-Cystic Fibrosis Participants
Serious events: 10 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cystic Fibrosis Participants
n=8 participants at risk
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=18 participants at risk
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Hepatobiliary disorders
Liver injury
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Investigations
Immunosuppressant drug level decreased
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
11.1%
2/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
11.1%
2/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
11.1%
2/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
Other adverse events
| Measure |
Cystic Fibrosis Participants
n=8 participants at risk
Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
Non-Cystic Fibrosis Participants
n=18 participants at risk
Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
0.00%
0/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Investigations
Immunosuppressant drug level increased
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
5.6%
1/18 • Up to Day 88
All enrolled participants were assessed for adverse events. Adverse events that were serious and/or related to study drug were collected in the study. Related adverse events were those classified as possibly, probably, or certainly related to study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
- Publication restrictions are in place
Restriction type: OTHER