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A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke (PRISMS)

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ClinicalTrials.gov Identifier: NCT02072226
Recruitment Status : Terminated (The study was terminated due to slow enrollment.)
First Posted : February 26, 2014
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Stroke
Interventions Drug: Alteplase
Drug: Alteplase Placebo
Drug: Aspirin
Drug: Aspirin Placebo
Enrollment 313
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description Participants received single dose of 0.9 milligram per kilogram (mg/kg) (maximal dose of 90 mg) intravenous (IV) alteplase and aspirin placebo orally. Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Period Title: Overall Study
Started 156 157
Completed 141 147
Not Completed 15 10
Reason Not Completed
Lost to Follow-up             11             7
Patient Non-compliance             2             3
Death             1             0
Patient Withdrawal of Consent             1             0
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin Total
Hide Arm/Group Description Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally. Participants received single dose of IV alteplase placebo and 325 mg aspirin orally. Total of all reporting groups
Overall Number of Baseline Participants 156 157 313
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 157 participants 313 participants
61.94  (13.53) 61.20  (13.05) 61.57  (13.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 313 participants
Female
79
  50.6%
65
  41.4%
144
  46.0%
Male
77
  49.4%
92
  58.6%
169
  54.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 313 participants
Hispanic or Latino
14
   9.0%
18
  11.5%
32
  10.2%
Not Hispanic or Latino
138
  88.5%
135
  86.0%
273
  87.2%
Not Reported
4
   2.6%
3
   1.9%
7
   2.2%
Unknown
0
   0.0%
1
   0.6%
1
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 313 participants
American Indian or Alaska Native
1
   0.6%
3
   1.9%
4
   1.3%
Asian
0
   0.0%
1
   0.6%
1
   0.3%
Black or African American
35
  22.4%
27
  17.2%
62
  19.8%
White
117
  75.0%
126
  80.3%
243
  77.6%
Other
1
   0.6%
0
   0.0%
1
   0.3%
Unknown
2
   1.3%
0
   0.0%
2
   0.6%
Total National Institutes of Health Stroke Scale (NIHSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 156 participants 157 participants 313 participants
2.3  (1.21) 2.1  (1.15) 2.2  (1.18)
[1]
Measure Description: NIHSS measures stroke symptoms. It has 11 main items which score between 0 and 4. A score of 0 typically indicates normal function, and a higher score indicates more symptoms. The individual scores from each item are summed to calculate total NIHSS score. Total NIHSS score ranges from 0 to 42, with 0 indicating no stroke symptoms, and a higher score indicating more symptoms.
1.Primary Outcome
Title Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90
Hide Description mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all randomized participants.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 156 157
Measure Type: Number
Unit of Measure: percentage of participants
78.2 81.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alteplase + Aspirin Placebo, Alteplase Placebo + Aspirin
Comments [Not Specified]
Type of Statistical Test Other
Comments Confidence Interval
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-9.44 to 7.25
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Distribution of Participants Across the Ordinal mRS
Hide Description mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 156 157
Measure Type: Number
Unit of Measure: percentage of participants
mRS at Day 90 - 0 44.9 50.3
mRS at Day 90 - 1 33.3 31.2
mRS at Day 90 - 2 11.5 11.5
mRS at Day 90 - 3 2.6 3.2
mRS at Day 90 - 4 5.1 2.5
mRS at Day 90 - 5 or 6 (death) 2.6 1.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alteplase + Aspirin Placebo, Alteplase Placebo + Aspirin
Comments [Not Specified]
Type of Statistical Test Other
Comments Confidence Interval
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.810
Confidence Interval (2-Sided) 95%
0.527 to 1.244
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
Hide Description Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0-1, National Institutes of Health Stroke Scale (NIHSS) Score 0-1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0-1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 156 157
Measure Type: Number
Unit of Measure: percentage of participants
mRS 0 - 1 at Day 90 Number Analyzed 156 participants 157 participants
78.2 81.5
NIHSS 0 - 1 at Day 90 Number Analyzed 127 participants 120 participants
85.0 81.7
BI >= 95 at Day 90 Number Analyzed 135 participants 133 participants
79.3 88.7
GOS = 1 at Day 90 Number Analyzed 135 participants 132 participants
81.5 85.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alteplase + Aspirin Placebo, Alteplase Placebo + Aspirin
Comments [Not Specified]
Type of Statistical Test Other
Comments Confidence Interval
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.858
Confidence Interval (2-Sided) 95%
0.529 to 1.393
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )
Hide Description ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Time Frame Within 36 hours after study drug administration on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants, who received any amount of study drug.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
3.2 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alteplase + Aspirin Placebo, Alteplase Placebo + Aspirin
Comments [Not Specified]
Type of Statistical Test Other
Comments Confidence Interval
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 3.25
Confidence Interval (2-Sided) 95%
0.75 to 7.38
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Any ICH
Hide Description To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Time Frame Within 36 hours after study drug administration on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants, who received any amount of study drug.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
Any ICH within 36 hours reported by site 7.1 2.6
Any ICH within 36 hours reported by central reader 7.1 3.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alteplase + Aspirin Placebo, Alteplase Placebo + Aspirin
Comments Any ICH within 36 hours reported by site
Type of Statistical Test Other
Comments Confidence Interval
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 4.53
Confidence Interval (2-Sided) 95%
-0.34 to 10.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alteplase + Aspirin Placebo, Alteplase Placebo + Aspirin
Comments Any ICH within 36 hours reported by central reader
Type of Statistical Test Other
Comments Confidence Interval
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 3.87
Confidence Interval (2-Sided) 95%
-1.23 to 9.49
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Mortality
Hide Description Reported here is the percentage of participants who died due to any cause during the study.
Time Frame From baseline to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants, who received any amount of study drug.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
0.6 0
7.Secondary Outcome
Title Percentage of Participants Who Died Due to Stroke and Neurological Disorders
Hide Description Reported here is the percentage of participants who died due to stroke and neurological disorders.
Time Frame From baseline to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants, who received any amount of study drug.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants, who received any amount of study drug.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
77.3 68.0
9.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events
Hide Description A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Time Frame From baseline to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants, who received any amount of study drug.
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description:
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
Overall Number of Participants Analyzed 154 153
Measure Type: Number
Unit of Measure: percentage of participants
26.0 13.1
Time Frame Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Adverse Event Reporting Description Safety population included all participants, who received any amount of study drug.
 
Arm/Group Title Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Hide Arm/Group Description Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally. Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
All-Cause Mortality
Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/154 (0.65%)   0/153 (0.00%) 
Hide Serious Adverse Events
Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   40/154 (25.97%)   20/153 (13.07%) 
Blood and lymphatic system disorders     
Anaemia  1  1/154 (0.65%)  0/153 (0.00%) 
Splenic embolism  1  0/154 (0.00%)  1/153 (0.65%) 
Cardiac disorders     
Cardiac failure  1  2/154 (1.30%)  0/153 (0.00%) 
Cardiogenic shock  1  2/154 (1.30%)  0/153 (0.00%) 
Sinus node dysfunction  1  1/154 (0.65%)  1/153 (0.65%) 
Acute left ventricular failure  1  1/154 (0.65%)  0/153 (0.00%) 
Acute myocardial infarction  1  0/154 (0.00%)  1/153 (0.65%) 
Cardiac aneurysm  1  0/154 (0.00%)  1/153 (0.65%) 
Cardiac failure acute  1  1/154 (0.65%)  0/153 (0.00%) 
Cardiac failure congestive  1  1/154 (0.65%)  0/153 (0.00%) 
Cardiomyopathy  1  1/154 (0.65%)  0/153 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/154 (0.00%)  1/153 (0.65%) 
Vertigo positional  1  1/154 (0.65%)  0/153 (0.00%) 
Eye disorders     
Retinal detachment  1  0/154 (0.00%)  1/153 (0.65%) 
Vitreous haemorrhage  1  1/154 (0.65%)  0/153 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  0/154 (0.00%)  1/153 (0.65%) 
Duodenal ulcer  1  1/154 (0.65%)  0/153 (0.00%) 
Gastritis  1  0/154 (0.00%)  1/153 (0.65%) 
Nausea  1  1/154 (0.65%)  0/153 (0.00%) 
Volvulus  1  1/154 (0.65%)  0/153 (0.00%) 
General disorders     
Asthenia  1  0/154 (0.00%)  1/153 (0.65%) 
Gait disturbance  1  1/154 (0.65%)  0/153 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  1/154 (0.65%)  0/153 (0.00%) 
Infections and infestations     
Urinary tract infection  1  2/154 (1.30%)  0/153 (0.00%) 
Ophthalmic herpes zoster  1  1/154 (0.65%)  0/153 (0.00%) 
Pneumonia  1  1/154 (0.65%)  0/153 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/154 (0.00%)  1/153 (0.65%) 
Fracture displacement  1  1/154 (0.65%)  0/153 (0.00%) 
Subarachnoid haemorrhage  1  0/154 (0.00%)  1/153 (0.65%) 
Investigations     
Haemoglobin decreased  1  1/154 (0.65%)  0/153 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/154 (0.65%)  0/153 (0.00%) 
Hyperkalaemia  1  1/154 (0.65%)  0/153 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/154 (0.65%)  0/153 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign ovarian tumour  1  1/154 (0.65%)  0/153 (0.00%) 
Bladder cancer  1  1/154 (0.65%)  0/153 (0.00%) 
Lung neoplasm malignant  1  1/154 (0.65%)  0/153 (0.00%) 
Nervous system disorders     
Ischaemic stroke  1  5/154 (3.25%)  2/153 (1.31%) 
Stroke in evolution  1  5/154 (3.25%)  1/153 (0.65%) 
Seizure  1  2/154 (1.30%)  2/153 (1.31%) 
Transient ischaemic attack  1  1/154 (0.65%)  3/153 (1.96%) 
Haemorrhagic transformation stroke  1  2/154 (1.30%)  1/153 (0.65%) 
Carotid artery stenosis  1  1/154 (0.65%)  1/153 (0.65%) 
Cerebral haemorrhage  1  2/154 (1.30%)  0/153 (0.00%) 
Cerebrovascular accident  1  0/154 (0.00%)  2/153 (1.31%) 
Haemorrhage intracranial  1  2/154 (1.30%)  0/153 (0.00%) 
Carotid arteriosclerosis  1  0/154 (0.00%)  1/153 (0.65%) 
Embolic stroke  1  0/154 (0.00%)  1/153 (0.65%) 
Hemiparesis  1  1/154 (0.65%)  0/153 (0.00%) 
Ischaemic cerebral infarction  1  1/154 (0.65%)  0/153 (0.00%) 
Sciatica  1  1/154 (0.65%)  0/153 (0.00%) 
Toxic encephalopathy  1  1/154 (0.65%)  0/153 (0.00%) 
Tremor  1  0/154 (0.00%)  1/153 (0.65%) 
Product Issues     
Device loosening  1  1/154 (0.65%)  0/153 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/154 (0.65%)  0/153 (0.00%) 
Renal embolism  1  0/154 (0.00%)  1/153 (0.65%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/154 (0.00%)  1/153 (0.65%) 
Respiratory distress  1  1/154 (0.65%)  0/153 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/154 (0.65%)  1/153 (0.65%) 
Vascular disorders     
Deep vein thrombosis  1  1/154 (0.65%)  0/153 (0.00%) 
Hypotension  1  0/154 (0.00%)  1/153 (0.65%) 
Orthostatic hypotension  1  1/154 (0.65%)  0/153 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alteplase + Aspirin Placebo Alteplase Placebo + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   49/154 (31.82%)   53/153 (34.64%) 
Gastrointestinal disorders     
Nausea  1  9/154 (5.84%)  13/153 (8.50%) 
Constipation  1  8/154 (5.19%)  10/153 (6.54%) 
Metabolism and nutrition disorders     
Hyperlipidaemia  1  7/154 (4.55%)  12/153 (7.84%) 
Hypokalaemia  1  9/154 (5.84%)  9/153 (5.88%) 
Nervous system disorders     
Headache  1  25/154 (16.23%)  26/153 (16.99%) 
Vascular disorders     
Hypertension  1  11/154 (7.14%)  10/153 (6.54%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
The study was terminated early due to low enrollment, leading to smaller number of participants analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02072226    
Other Study ID Numbers: ML29093
First Submitted: February 24, 2014
First Posted: February 26, 2014
Results First Submitted: March 7, 2018
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018