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Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03188991
Recruitment Status : Completed
First Posted : June 16, 2017
Results First Posted : June 8, 2021
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Mucinous-Cystic Neoplasm
Intervention Drug: NanoPac®
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Hide Arm/Group Description

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Period Title: Overall Study
Started 3 3 3 11
Completed 3 3 3 10
Not Completed 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) Total
Hide Arm/Group Description

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 10 19
Hide Baseline Analysis Population Description
All enrolled subjects (n=20) who received at least one NanoPac injection (n=19) were designated as the Safety Population, and included in the analysis population for all outcome analyses. The subject who withdrew consent prior to any NanoPac treatment is not included in the analysis population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 10 participants 19 participants
66.3  (8.3) 73.7  (11.5) 59.7  (9.1) 67.8  (6.6) 67.2  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 10 participants 19 participants
Female
3
 100.0%
2
  66.7%
2
  66.7%
6
  60.0%
13
  68.4%
Male
0
   0.0%
1
  33.3%
1
  33.3%
4
  40.0%
6
  31.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 10 participants 19 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
3
  30.0%
3
  15.8%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
3
 100.0%
7
  70.0%
16
  84.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 10 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  66.7%
0
   0.0%
0
   0.0%
1
  10.0%
3
  15.8%
White
1
  33.3%
3
 100.0%
3
 100.0%
8
  80.0%
15
  78.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
1
   5.3%
Body Mass Index (BMI) (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 3 participants 3 participants 3 participants 10 participants 19 participants
34.83  (11.71) 27.93  (10.20) 26.67  (3.43) 32.82  (7.17) 31.39  (7.91)
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Hide Description Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Time Frame Up to 6 (six) months after first NanoPac® injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Hide Arm/Group Description:

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Overall Number of Participants Analyzed 3 3 3 10
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3
 100.0%
3
 100.0%
9
  90.0%
2.Secondary Outcome
Title Cyst Volume Response
Hide Description Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Time Frame Screening and 6 (six) months after first NanoPac® injection
Hide Outcome Measure Data
Hide Analysis Population Description
In the dose escalation phase, baseline imaging data for the measurement of cyst diameters and calculation of cyst volume was available in all subjects. At Week 12, 18 of 19 subjects had three cyst diameters available for analyses. At Week 24, 17 of 19 subjects had three cyst diameters available for analyses.
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Hide Arm/Group Description:

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Overall Number of Participants Analyzed 3 3 3 10
Mean (Standard Deviation)
Unit of Measure: mL
Screening 7.770  (3.283) 4.810  (5.109) 10.960  (8.484) 11.442  (8.132)
Week 12 5.710  (3.892) 3.453  (2.188) 9.633  (9.284) 12.293  (10.755)
Week 24/EOS 4.140  (3.920) 4.383  (0.521) 8.533  (7.183) 11.138  (11.931)
Time Frame AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Hide Arm/Group Description

Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection.

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

All-Cause Mortality
Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/3 (0.00%)      1/3 (33.33%)      3/10 (30.00%)    
Gastrointestinal disorders         
Abdominal Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Obstruction Gastric  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast Cancer  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders         
Hepatic encephalopathy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders         
Organising pneumonia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Escalation: NanoPac® 6 mg/mL Dose Escalation: NanoPac® 10 mg/mL Dose Escalation: NanoPac® 15 mg/mL Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      9/10 (90.00%)    
Cardiac disorders         
Atrial Fibrillation  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  2/3 (66.67%)  2 2/3 (66.67%)  3 1/3 (33.33%)  1 0/10 (0.00%)  0
Abdominal distension  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Abdominal pain lower  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Abdominal pain upper  1  0/3 (0.00%)  0 2/3 (66.67%)  3 0/3 (0.00%)  0 1/10 (10.00%)  1
Diarrhoea  1  1/3 (33.33%)  1 2/3 (66.67%)  2 0/3 (0.00%)  0 1/10 (10.00%)  1
Duodenal ulcer, obstructive  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
GI Motility disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Glossodynia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Ileal stenosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Nausea  1  1/3 (33.33%)  1 2/3 (66.67%)  3 1/3 (33.33%)  1 1/10 (10.00%)  1
Obstruction gastric  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Oesophagitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Vomiting  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
General disorders         
Asthenia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/10 (0.00%)  0
Chills  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Device complication  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Fatigue  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  3 1/10 (10.00%)  1
Hernia pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Oedema peripheral  1  2/3 (66.67%)  2 0/3 (0.00%)  0 2/3 (66.67%)  2 1/10 (10.00%)  2
Pyrexia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations         
Bacterial infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Infected bite  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Sinusitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  2
URTI  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
UTI  1  1/3 (33.33%)  1 1/3 (33.33%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Vulvovaginal mycotic infec.  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 0/10 (0.00%)  0
Post procedural complication  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Procedural pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Investigations         
Platelet count increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
WBC count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Metabolism and nutrition disorders         
Decreased appetite  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/10 (10.00%)  1
Gout  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  2
Hyperkalaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders         
Medial tibial stress syndrome  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Muscular weakness  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal discomfort  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Myopathy  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  2 0/10 (0.00%)  0
Headache  1  0/3 (0.00%)  0 2/3 (66.67%)  4 0/3 (0.00%)  0 1/10 (10.00%)  1
Hepatic encephalopathy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Migraine  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Neuropathy peripheral  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Radiculopathy  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bradypnoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Organising pneumonia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Wheezing  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Rash  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gere S. diZerega, MD
Organization: US Biotest, Inc.
Phone: 805.595.1300
EMail: gere.dizerega@usbiotest.com
Layout table for additonal information
Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03188991    
Other Study ID Numbers: NANOPAC-2017-01
First Submitted: June 13, 2017
First Posted: June 16, 2017
Results First Submitted: May 12, 2021
Results First Posted: June 8, 2021
Last Update Posted: June 14, 2021