Trial Outcomes & Findings for Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection (NCT NCT02534350)
NCT ID: NCT02534350
Last Updated: 2018-11-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to 7 days
Results posted on
2018-11-28
Participant Flow
Participants were enrolled at sites in Europe, North America, and Australia.The first participant was screened on 31 December 2015 and the last study visit occurred on 27 September 2017.
111 participants were screened.
Participant milestones
| Measure |
Presatovir
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via nasogastric (NG) tube once daily
|
Placebo
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
20
|
|
Overall Study
COMPLETED
|
37
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Presatovir
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via nasogastric (NG) tube once daily
|
Placebo
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Overall Study
Randomized But Not Treated
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrew Consent
|
2
|
0
|
Baseline Characteristics
Participants in the Safety Analysis Set with available data were analyzed.
Baseline characteristics by cohort
| Measure |
Presatovir
n=40 Participants
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=20 Participants
Tablets administered orally or via NG tube once daily for 14 days
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 12.54 • n=40 Participants
|
55.1 years
STANDARD_DEVIATION 14.23 • n=20 Participants
|
56.0 years
STANDARD_DEVIATION 13.02 • n=60 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=40 Participants
|
10 Participants
n=20 Participants
|
29 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=40 Participants
|
10 Participants
n=20 Participants
|
31 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=40 Participants
|
19 Participants
n=20 Participants
|
55 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=40 Participants
|
16 Participants
n=20 Participants
|
52 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
2 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=60 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=40 Participants
|
12 Participants
n=20 Participants
|
37 Participants
n=60 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=60 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=60 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=60 Participants
|
|
Nasal Viral Load
|
5.88 log10 copies/mL
STANDARD_DEVIATION 2.088 • n=37 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
6.59 log10 copies/mL
STANDARD_DEVIATION 2.092 • n=20 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
6.13 log10 copies/mL
STANDARD_DEVIATION 2.098 • n=57 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
|
inFLUenza Patient-Reported Outcome (FLU-PRO) Score
|
2.05 units on a scale
STANDARD_DEVIATION 0.607 • n=37 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
2.11 units on a scale
STANDARD_DEVIATION 0.684 • n=18 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
2.07 units on a scale
STANDARD_DEVIATION 0.628 • n=55 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
|
The Forced Expiratory Volume in One Second (FEV1) % Predicted
|
63.64 percent FEV1
STANDARD_DEVIATION 24.787 • n=40 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
61.95 percent FEV1
STANDARD_DEVIATION 18.625 • n=19 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
63.10 percent FEV1
STANDARD_DEVIATION 22.834 • n=59 Participants • Participants in the Safety Analysis Set with available data were analyzed.
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: Participants in the Full Analysis Set (participants who received at least 1 full dose of study drug and had an RSV viral load ≥ lower limit of quantification (LLOQ) of the real-time quantitative polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab) with available data were analyzed .
Outcome measures
| Measure |
Presatovir
n=35 Participants
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=19 Participants
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set
|
-0.73 log10 copies/mL
Standard Deviation 0.938
|
-0.90 log10 copies/mL
Standard Deviation 0.815
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Presatovir
n=16 Participants
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=11 Participants
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median
|
-0.83 log10 copies/mL
Standard Deviation 1.013
|
-0.83 log10 copies/mL
Standard Deviation 0.757
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Participants in the Full Analysis Set with available data were analyzed.
The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Outcome measures
| Measure |
Presatovir
n=33 Participants
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=17 Participants
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7
|
-0.27 units on a scale
Standard Deviation 0.313
|
-0.31 units on a scale
Standard Deviation 0.298
|
SECONDARY outcome
Timeframe: Baseline; Day 28Population: Participants in the Full Analysis Set with available data were analyzed.
FEV1 is defined as forced expiratory volume in the first second.
Outcome measures
| Measure |
Presatovir
n=30 Participants
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=17 Participants
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Percent Change From Study Baseline in FEV1% Predicted Value
|
22.69 percent change
Standard Deviation 27.437
|
26.36 percent change
Standard Deviation 23.312
|
Adverse Events
Presatovir
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Presatovir
n=40 participants at risk
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=20 participants at risk
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Psychiatric disorders
Mental status changes
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
10.0%
2/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
Other adverse events
| Measure |
Presatovir
n=40 participants at risk
200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14 administered orally or via NG tube once daily
|
Placebo
n=20 participants at risk
Tablets administered orally or via NG tube once daily for 14 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
15.0%
3/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Cardiac disorders
Palpitations
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Eye disorders
Vision blurred
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Eye disorders
Visual impairment
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
20.0%
4/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40 • Baseline up to Day 28
Safety Analysis Set
|
15.0%
3/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
3/40 • Baseline up to Day 28
Safety Analysis Set
|
15.0%
3/20 • Baseline up to Day 28
Safety Analysis Set
|
|
General disorders
Fatigue
|
10.0%
4/40 • Baseline up to Day 28
Safety Analysis Set
|
15.0%
3/20 • Baseline up to Day 28
Safety Analysis Set
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Infections and infestations
Candida infection
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
10.0%
2/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Investigations
Forced expiratory flow decreased
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Investigations
Forced expiratory volume decreased
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Investigations
Haemoglobin decreased
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Investigations
Transaminases increased
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • Baseline up to Day 28
Safety Analysis Set
|
25.0%
5/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
12.5%
5/40 • Baseline up to Day 28
Safety Analysis Set
|
20.0%
4/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Nervous system disorders
Tremor
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Psychiatric disorders
Confusional state
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
10.0%
2/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
10.0%
2/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
5.0%
2/40 • Baseline up to Day 28
Safety Analysis Set
|
0.00%
0/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • Baseline up to Day 28
Safety Analysis Set
|
5.0%
1/20 • Baseline up to Day 28
Safety Analysis Set
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER