Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02319031
• Collaborator: (none)
• Enrollment: 53
• Locations: 10
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks) Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing	Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin
Active Comparator: Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks) Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing	Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) [Follow-up Week 12]

   SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.

Secondary Outcome Measures

1. Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24) [Follow-up Weeks 4 and 24]

   SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.

2. Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities [Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)]

   Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.

Eligibility Criteria

Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have Genotype 3 Chronic HCV

• Must have advanced fibrosis (F3) or compensated cirrhosis (F4)

• HCV RNA Viral load ≥ 10,000 IU/mL

• HCV Treatment naive or treatment-experienced

Exclusion Criteria:

• Non Genotype 3 or mixed genotypes

• Non advanced fibrosis or compensated cirrhosis

• Any prior treatment with NS5A inhibitors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Darlinghurst	New South Wales	Australia	2010
2	Local Institution	Greenslopes	Queensland	Australia	4120
3	Local Institution	Adelaide	South Australia	Australia	5000
4	Local Institution	Clayton	Victoria	Australia	3168
5	Local Institution	Fitzroy	Victoria	Australia	3065
6	Local Institution	Heidelberg	Victoria	Australia	3084
7	Local Institution	Creteil Cedex		France	94010
8	Local Institution	Grenoble Cedex 09		France	38043
9	Local Institution	Paris Cedex 14		France	75679
10	Local Institution	Vandoeuvre Les Nancy		France	54511

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol - Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS clinical trial educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02319031
• Other Study ID Numbers: AI444-326
• First Posted: Dec 18, 2014
• Last Update Posted: Jan 27, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Hepatitis C; Hepatitis; Ribavirin; Sofosbuvir

Study Results

Participant Flow

Recruitment Details	53 participants were enrolled. 50 participants were randomized and treated (24 to 12 week arm, 26 to 16 week arm). Reason for non-randomization was 3 no longer met study criteria.

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)	Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Arm/Group Description	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
Period Title: Treatment Period
STARTED	24	26
COMPLETED	23	26
NOT COMPLETED	1	0
Period Title: Treatment Period
STARTED	23	26
COMPLETED	23	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)	Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)	Total
Arm/Group Description	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram	Total of all reporting groups
Overall Participants	24	26	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.0 (7.77)	55.0 (5.75)	54.1 (6.80)
Age, Customized (participants) [Number]
<65	23 95.8%	26 100%	49 98%
>=65	1 4.2%	0 0%	1 2%
Gender (Count of Participants)
Female	6 25%	4 15.4%	10 20%
Male	18 75%	22 84.6%	40 80%

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
Description	SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Time Frame	Follow-up Week 12

Outcome Measure Data

Analysis Population Description

All treated participants: Enrolled participants who received at least 1 dose of study drug

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)	Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Arm/Group Description	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
Measure Participants	24	26
Number (95% Confidence Interval) [percentage of participants]	87.5 364.6%	92.3 355%

2. Secondary Outcome

Title	Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)
Description	SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Time Frame	Follow-up Weeks 4 and 24

Outcome Measure Data

Analysis Population Description

All treated participants: Enrolled participants who received at least 1 dose of study drug

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)	Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Arm/Group Description	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
Measure Participants	24	26
Follow-up Week 4 (SVR4)	87.5 364.6%	96.2 370%
Follow-up Week 24 (SVR24)	87.5 364.6%	92.3 355%

3. Secondary Outcome

Title	Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities
Description	Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.
Time Frame	Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)

Outcome Measure Data

Analysis Population Description

All treated participants: Enrolled participants who received at least 1 dose of study drug

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)	Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Arm/Group Description	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
Measure Participants	24	26
Death	1 4.2%	0 0%
SAEs	2 8.3%	3 11.5%
Discontinuation due to AEs	0 0%	0 0%
Grade 3/4 AEs	2 8.3%	2 7.7%
Grade 3/4 Laboratory Abnormalities	1 4.2%	2 7.7%

Adverse Events

Time Frame	SAEs were reported from date of first dose of study drug to 30 days post discontinuation of the last dose which was up to 16 weeks or 20 weeks depending on the randomized treatment group. Non-serious AEs were reported from date of first dose of study drug to 7 days post discontinuation of the last dose which was up to 13 weeks or 17 weeks depending on the randomized treatment group.
Adverse Event Reporting Description	Study initiated February 2015; study completed December 2015
Arm/Group Title	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)		Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Arm/Group Description	Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram		Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
All Cause Mortality
	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)		Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)		Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/24 (8.3%)		3/26 (11.5%)
Cardiac disorders
Congestive cardiomyopathy	1/24 (4.2%)		0/26 (0%)
Infections and infestations
Pneumonia	0/24 (0%)		1/26 (3.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/24 (0%)		1/26 (3.8%)
Nervous system disorders
Somnolence	1/24 (4.2%)		0/26 (0%)
Vascular disorders
Arteriosclerosis	0/24 (0%)		1/26 (3.8%)
Other (Not Including Serious) Adverse Events
	Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)		Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/24 (87.5%)		22/26 (84.6%)
Blood and lymphatic system disorders
Anaemia	0/24 (0%)		2/26 (7.7%)
Gastrointestinal disorders
Diarrhoea	1/24 (4.2%)		4/26 (15.4%)
Abdominal pain	0/24 (0%)		2/26 (7.7%)
Mouth ulceration	0/24 (0%)		2/26 (7.7%)
Nausea	3/24 (12.5%)		1/26 (3.8%)
Abdominal discomfort	0/24 (0%)		2/26 (7.7%)
Abdominal pain upper	2/24 (8.3%)		0/26 (0%)
General disorders
Fatigue	6/24 (25%)		7/26 (26.9%)
Asthenia	1/24 (4.2%)		5/26 (19.2%)
Metabolism and nutrition disorders
Decreased appetite	0/24 (0%)		2/26 (7.7%)
Musculoskeletal and connective tissue disorders
Back pain	0/24 (0%)		3/26 (11.5%)
Nervous system disorders
Headache	7/24 (29.2%)		5/26 (19.2%)
Lethargy	2/24 (8.3%)		2/26 (7.7%)
Psychiatric disorders
Depression	1/24 (4.2%)		2/26 (7.7%)
Irritability	5/24 (20.8%)		2/26 (7.7%)
Insomnia	8/24 (33.3%)		7/26 (26.9%)
Depressed mood	1/24 (4.2%)		2/26 (7.7%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/24 (8.3%)		3/26 (11.5%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	2/24 (8.3%)		0/26 (0%)
Pruritus	1/24 (4.2%)		2/26 (7.7%)
Dry skin	2/24 (8.3%)		0/26 (0%)
Photosensitivity reaction	2/24 (8.3%)		0/26 (0%)
Vascular disorders
Hypertension	0/24 (0%)		3/26 (11.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.