FIT: A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

• Sponsor: Rigel Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02076399
• Collaborator: (none)
• Enrollment: 76
• Locations: 52
• Arms: 2
• Actual Duration (Months): 21.3
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenic Purpura	Drug: Fostamatinib disodium; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
• Actual Study Start Date: Jul 14, 2014
• Actual Primary Completion Date: Apr 21, 2016
• Actual Study Completion Date: Apr 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fostamatinib Disodium Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.	Drug: Fostamatinib disodium; Fostamatinib (100 mg PO bid or 150 mg PO bid); Other Names: R935788 R788 Fostamatinib
Other: Placebo Placebo tablet PO bid (morning and evening) over the course of 24 weeks	Drug: Placebo; Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24) [From Week 14 to Week 24]

   A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24

Secondary Outcome Measures

1. Number of Participants With Platelet Count ≥ 50,000/µL at Week 12 [Week 12]

   Platelet Count ≥ 50,000/µL at Week 12

2. Number of Participants With Platelet Count ≥ 50,000/µL at Week 24 [Week 24]

   Platelet Count ≥ 50,000/µL at Week 24

3. Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12. [Baseline to Week 12]

   Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12.

4. Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24. [Baseline to Week 24]

   Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24.

5. Mean of the ITP Bleeding Score (IBLS) [Assessed over the 24-week study period]

   The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data. The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.

6. Mean of World Health Organization (WHO) Bleeding Scale [Assessed over the 24-week study period]

   The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data. The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of persistent/chronic ITP for at least 3 months.

• Average platelet count < 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

Exclusion Criteria:

• Clinical diagnosis of autoimmune hemolytic anemia

• Uncontrolled or poorly controlled hypertension

• History of coagulopathy including prothrombotic conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Associates	Tucson	Arizona	United States	85710
2	University of Southern California	Los Angeles	California	United States	90089
3	Lakeland Regional Cancer Center	Lakeland	Florida	United States	33805-1965
4	Bleeding & Clotting Disorders Institute	Peoria	Illinois	United States	61614
5	Horizon Oncology Research, Inc	Lafayette	Indiana	United States	47905
6	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20817
7	Weill Cornell Medical College/New York Presbyterian Hospital	New York	New York	United States	10065
8	Pitt County Memorial Hospital	Greenville	North Carolina	United States	27858
9	Bill Hefner VA Medical Center	Salisbury	North Carolina	United States	28144
10	Cleveland Clinic	Cleveland	Ohio	United States	44195
11	Signal Point Clinical Research Center LLC	Middletown	Ohio	United States	45042
12	University of Utah Health Sciences Center	Salt Lake City	Utah	United States	84132
13	University of Virginia	Charlottesville	Virginia	United States	22908
14	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
15	St George Hospital	Kogarah	New South Wales	Australia	2217
16	Liverpool Hospital	Liverpool	New South Wales	Australia	2170
17	Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
18	Westmead Hospital	Westmead	New South Wales	Australia	2145
19	Launceston General Hospital	Launceston	Tasmania	Australia	7250
20	Frankston Hospital	Frankston	Victoria	Australia	3199
21	Dept of Haematology, The Alfred Hospital and Monash Medical Centre	Melbourne	Victoria	Australia	3004
22	Perth Blood Institute	Nedlands	Western Australia	Australia	6009
23	Hamilton Health Sciences Corporation	Hamilton	Ontario	Canada	L8N 3Z5
24	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1 H8L6
25	St. Michael's Hospital	Toronto	Ontario	Canada	M5B1W8
26	Herlev Hospital University of Copenhagen, Department of Hematology L124	Herlev	DK	Denmark	2730
27	Dept. of Haematology, Odense University Hospital	Odense C	DK	Denmark	DK-5000
28	Hematological department, Roskilde Hospital	Roskilde	DK	Denmark	4000
29	Aarhus University Hospital	Aalborg		Denmark	9000
30	Semmelweis University 1st	Budapest		Hungary	H-1083
31	University of Debrecen	Debrecen		Hungary	H-1083
32	Pecs University	Pecs		Hungary	H-7624
33	Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna	Bologna		Italy	40138
34	Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia	Milano		Italy	20132
35	Universitã Federico II di Napoli	Napoli		Italy	80131
36	OspedaleCivile-ClinicaEmatologica/PUGD	Udine		Italy	33100
37	ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza	Vicenza		Italy
38	HAGA ziekenhuis	Haag	NL	Netherlands	2545 CH
39	Kent & Canterbury Hospital	Kent	Canterbury	United Kingdom	CT1 3NG
40	Colchester General Hospital	Colchester	Essex	United Kingdom	CO4 5JL
41	Royal Liverpool University Hospital	Liverpool	UK	United Kingdom	L78XP
42	St. James's Hospital	Leeds		United Kingdom	LS9 7TF
43	Leicester Royal Infirmary	Leicester		United Kingdom	LE1 5WW
44	Royal London Hospital	London		United Kingdom	E1 2ES
45	Hammersmith Hospital, Catherine Lewis Centre	London		United Kingdom	W12 0HS
46	University College Hospital	London		United Kingdom	WC1E 6HX
47	Manchester Royal Infirmary	Manchester		United Kingdom	M139WL
48	Royal Victoria Infirmary	Newcastle-upon-Tyne		United Kingdom	NE1 4LP
49	James Paget University Hospital	Norfolk		United Kingdom	NR31 6LA
50	Oxford University Hospital	Oxford		United Kingdom	OX3 9BQ
51	University Hospital of North Staffordshire	Stoke-on-Trent		United Kingdom	ST4 6QG
52	Sandwell General Hospital	West Bromwich		United Kingdom	B71 4HJ

Sponsors and Collaborators

• Rigel Pharmaceuticals

Investigators

• Study Director: Rigel Pharmaceuticals, Inc., Rigel Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rigel Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02076399
• Other Study ID Numbers: C-935788-047; 2013-005452-15
• First Posted: Mar 3, 2014
• Last Update Posted: Feb 12, 2019
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Rigel Pharmaceuticals: Persistent Immune Thrombocytopenic Purpura; Chronic Immune Thrombocytopenic Purpura
• Additional relevant MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic

Study Results

Participant Flow

Recruitment Details	76 patients were enrolled from July 2014 to April 2016

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Period Title: Overall Study
STARTED	51	25
COMPLETED	12	1
NOT COMPLETED	39	24

Baseline Characteristics

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient	Total
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo	Total of all reporting groups
Overall Participants	51	25	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.3 (17.7)	53.2 (16.0)	56.0 (17.2)
Sex: Female, Male (Count of Participants)
Female	30 58.8%	17 68%	47 61.8%
Male	21 41.2%	8 32%	29 38.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 5.9%	1 4%	4 5.3%
Not Hispanic or Latino	48 94.1%	24 96%	72 94.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 5.9%	2 8%	5 6.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 3.9%	2 8%	4 5.3%
White	44 86.3%	21 84%	65 85.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 3.9%	0 0%	2 2.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)
Description	A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24
Time Frame	From Week 14 to Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	51	25
Count of Participants [Participants]	9 17.6%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fostamatinib Recipient, Placebo Recipient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0261
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	17.6
	Confidence Interval	(2-Sided) 95%; 7.2 to 28.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Description	Platelet Count ≥ 50,000/µL at Week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	51	25
Count of Participants [Participants]	11 21.6%	0 0%

3. Secondary Outcome

Title	Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Description	Platelet Count ≥ 50,000/µL at Week 24
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	51	25
Count of Participants [Participants]	8 15.7%	0 0%

4. Secondary Outcome

Title	Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12.
Description	Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	25	12
Count of Participants [Participants]	4 7.8%	0 0%

5. Secondary Outcome

Title	Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24.
Description	Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	25	12
Count of Participants [Participants]	4 7.8%	0 0%

6. Secondary Outcome

Title	Mean of the ITP Bleeding Score (IBLS)
Description	The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data. The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.
Time Frame	Assessed over the 24-week study period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	51	25
Mean (Standard Deviation) [scores on a scale]	0.13 (0.12)	0.14 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fostamatinib Recipient, Placebo Recipient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6642
	Comments	P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Mean of World Health Organization (WHO) Bleeding Scale
Description	The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data. The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.
Time Frame	Assessed over the 24-week study period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fostamatinib Recipient	Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)	Placebo
Measure Participants	51	25
Mean (Standard Deviation) [scores on a scale]	0.61 (0.66)	0.46 (0.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fostamatinib Recipient, Placebo Recipient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3365
	Comments	P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	24 Weeks
Arm/Group Title	Fostamatinib Recipient		Placebo Recipient
Arm/Group Description	Fostamatinib (100 mg PO bid or 150 mg PO bid)		Placebo
All Cause Mortality
	Fostamatinib Recipient		Placebo Recipient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		1/25 (4%)
Serious Adverse Events
	Fostamatinib Recipient		Placebo Recipient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/51 (15.7%)		5/25 (20%)
Blood and lymphatic system disorders
Anaemia	0/51 (0%)	0	1/25 (4%)	2
Febrile Neutropenia	1/51 (2%)	1	0/25 (0%)	0
Immune Thrombocytopenic Purpura	1/51 (2%)	1	0/25 (0%)	0
Thrombocytopenia	1/51 (2%)	2	0/25 (0%)	0
Cardiac disorders
Cardiac Failure Congestive	0/51 (0%)	0	1/25 (4%)	1
Eye disorders
Retinal Tear	1/51 (2%)	1	0/25 (0%)	0
Gastrointestinal disorders
Diarrhoea	1/51 (2%)	1	0/25 (0%)	0
Gastrointestinal Haemorrhage	0/51 (0%)	0	1/25 (4%)	2
Infections and infestations
Pneumonia	1/51 (2%)	1	0/25 (0%)	0
Sepsis	0/51 (0%)	0	1/25 (4%)	1
Nervous system disorders
Syncope	1/51 (2%)	1	0/25 (0%)	0
Reproductive system and breast disorders
Menorrhagia	0/51 (0%)	0	1/25 (4%)	1
Vaginal Haemorrhage	1/51 (2%)	1	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	0/51 (0%)	0	1/25 (4%)	1
Epistaxis	1/51 (2%)	2	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Fostamatinib Recipient		Placebo Recipient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/51 (96.1%)		19/25 (76%)
Blood and lymphatic system disorders
Anaemia	2/51 (3.9%)		2/25 (8%)
Gastrointestinal disorders
Diarrhoea	21/51 (41.2%)		4/25 (16%)
Nausea	15/51 (29.4%)		1/25 (4%)
Constipation	3/51 (5.9%)		1/25 (4%)
Abdominal pain	3/51 (5.9%)		0/25 (0%)
Flatulence	3/51 (5.9%)		0/25 (0%)
Vomiting	2/51 (3.9%)		2/25 (8%)
Rectal haemorrhage	0/51 (0%)		2/25 (8%)
General disorders
Fatigue	6/51 (11.8%)		1/25 (4%)
Pyrexia	2/51 (3.9%)		2/25 (8%)
Chest pain	4/51 (7.8%)		1/25 (4%)
Infections and infestations
Upper respiratory tract infection	5/51 (9.8%)		1/25 (4%)
Urinary tract infection	3/51 (5.9%)		0/25 (0%)
Injury, poisoning and procedural complications
Contusion	3/51 (5.9%)		0/25 (0%)
Investigations
Alanine aminotransferase increased	9/51 (17.6%)		0/25 (0%)
Aspartate aminotransferase increased	8/51 (15.7%)		0/25 (0%)
Blood pressure increased	3/51 (5.9%)		1/25 (4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	0/51 (0%)		2/25 (8%)
Nervous system disorders
Headache	7/51 (13.7%)		6/25 (24%)
Dizziness	9/51 (17.6%)		4/25 (16%)
Dysgeusia	4/51 (7.8%)		0/25 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	9/51 (17.6%)		4/25 (16%)
Dyspnoea	3/51 (5.9%)		3/25 (12%)
Oropharyngeal pain	1/51 (2%)		2/25 (8%)
Vascular disorders
Hypertension	13/51 (25.5%)		1/25 (4%)
Rash	4/51 (7.8%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.