STEALTHC-3: Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

• Sponsor: Romark Laboratories L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00637923
• Collaborator: (none)
• Enrollment: 112
• Locations: 10
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 11.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Nitazoxanide; Drug: Placebo; Biological: Peginterferon alfa-2a; Drug: Ribavirin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	Drug: Nitazoxanide; One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.; Other Names: Alinia ; Biological: Peginterferon alfa-2a; One weekly injection of 180µg of peginterferon α-2a for 48 weeks.; Other Names: PEGASYS ; Drug: Ribavirin; Weight-based ribavirin for 48 weeks.; Other Names: COPEGUS
Placebo Comparator: 2 One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	Drug: Placebo; One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.; Biological: Peginterferon alfa-2a; One weekly injection of 180µg of peginterferon α-2a for 48 weeks.; Other Names: PEGASYS ; Drug: Ribavirin; Weight-based ribavirin for 48 weeks.; Other Names: COPEGUS

Outcome Measures

Primary Outcome Measures

1. Sustained Virologic Response (HCV RNA Below Lower Limit of Detection) [24 weeks after end of treatment]

   Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.

Secondary Outcome Measures

1. End of Treatment Response (HCV RNA Below Lower Limit of Detection) [At end of treatment]

   Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.

2. Early Virologic Response (HCV RNA Below Lower Limit of Detection) [After 12 weeks combination treatment]

   Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.

3. Rapid Virologic Response (HCV RNA Below Lower Limit of Detection) [After 4 weeks combination treatment]

   Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.

4. Changes in ALT [From baseline to week 8]

   This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

5. Changes in ALT [From baseline to week 16]

   This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up

6. Changes in ALT [From baseline to end of treatment]

   This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

7. Changes in ALT [From baseline to end of follow up]

   This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Chronic hepatitis C genotype 1.

Exclusion Criteria:

• Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.

• Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.

• Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.

• Other causes of liver disease including autoimmune hepatitis.

• Transplant recipients receiving immune suppression therapy.

• Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).

• Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score >6 or Model for End-stage Liver Disease (MELD) score >8.

• Alcohol consumption of >40 grams per day or an alcohol use pattern that will interfere with the study.

• Absolute neutrophil count <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).

• Hypothyroidism or hyperthyroidism not effectively treated with medication.

• Hemoglobin A1C (HgbA1c) >7.5 or history of diabetes mellitus.

• Body Mass Index (BMI) >34.

• History or other clinical evidence of significant or unstable cardiac disease.

• History or other clinical evidence of chronic pulmonary disease associated with functional impairment.

• Serious or severe bacterial infection(s).

• Ulcerative or hemorrhagic/ischemic colitis.

• Pancreatitis.

• History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.

• History of uncontrolled severe seizure disorder.

• Requires concomitant theophylline or methadone.

• History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.

• History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.

• Hemoglobinopathies.

• History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto VA Healthcare System	Palo Alto	California	United States	94304
2	Yale University School of Medicine	New Haven	Connecticut	United States	06520
3	Bay Pines VA Healthcare System	Bay Pines	Florida	United States	33744
4	Florida Center for Gastroenterology	Largo	Florida	United States	33777
5	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30308
6	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
7	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
8	New York Presbyterian-Weill Medical College of Cornell University	New York	New York	United States	10021
9	Nashville Medical Research Institute	Nashville	Tennessee	United States	37205
10	Metropolitan Research	Fairfax	Virginia	United States	22031

Sponsors and Collaborators

• Romark Laboratories L.C.

Investigators

• Study Director: Emmet B Keeffe, MD, MACP, Romark Laboratories L.C.
• Principal Investigator: Norman Gitlin, MD, Atlanta Gastroenterology Associates
• Principal Investigator: Joseph K Lim, MD, Yale University
• Principal Investigator: Ira Jacobson, MD, New York Presbyterial-Weill Medical College of Cornell University
• Principal Investigator: Mitchell L Shiffman, MD, McGuire Veteran's Administration Medical Center
• Principal Investigator: Ronald E Pruitt, MD, Nashville Medical Research Institute
• Principal Investigator: Arthur Berman, DO, Florida Center for Gastroenterology
• Principal Investigator: Bruce Bacon, MD, St. Louis University Medical Center
• Principal Investigator: Nezam Afdhal, MD, Beth Israel Deaconess Medical Center
• Principal Investigator: David Johnson, MD, Bay Pines VA Healthcare System
• Principal Investigator: Raymond Chung, MD, Massachusetts General Hospital
• Principal Investigator: Vinod Rustgi, MD, Metropolitan Research
• Principal Investigator: Aijaz Ahmed, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Romark Laboratories L.C.
• ClinicalTrials.gov Identifier: NCT00637923
• Other Study ID Numbers: RM01-2026
• First Posted: Mar 18, 2008
• Last Update Posted: Feb 10, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Romark Laboratories L.C.: Hepatitis C, Chronic
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Peginterferon alfa-2a; Nitazoxanide

Study Results

Participant Flow

Recruitment Details	This study recruited patients from 13 study centers in the United States, including 2 Veterans Administration hospitals.

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Period Title: Overall Study
STARTED	75	37
COMPLETED	45	18
NOT COMPLETED	30	19

Baseline Characteristics

Arm/Group Title	NTZ+PR	Placebo+PR	Total
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	Total of all reporting groups
Overall Participants	75	37	112
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	74 98.7%	37 100%	111 99.1%
>=65 years	1 1.3%	0 0%	1 0.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (7)	51 (8)	50 (7)
Sex: Female, Male (Count of Participants)
Female	26 34.7%	13 35.1%	39 34.8%
Male	49 65.3%	24 64.9%	73 65.2%
Region of Enrollment (participants) [Number]
United States	75 100%	37 100%	112 100%

Outcome Measures

1. Primary Outcome

Title	Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Description	Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Time Frame	24 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	75	37
Responders	32 42.7%	13 35.1%
Non-responders	43 57.3%	24 64.9%

2. Secondary Outcome

Title	End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Description	Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Time Frame	At end of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	75	37
Responders	46 61.3%	18 48.6%
Non-responders	29 38.7%	19 51.4%

3. Secondary Outcome

Title	Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Description	Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Time Frame	After 12 weeks combination treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	75	37
Responders	45 60%	18 48.6%
Non-responders	30 40%	19 51.4%

4. Secondary Outcome

Title	Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Description	Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Time Frame	After 4 weeks combination treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	75	37
Responders	9 12%	7 18.9%
Non-responders	66 88%	30 81.1%

5. Secondary Outcome

Title	Changes in ALT
Description	This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame	From baseline to week 8

Outcome Measure Data

Analysis Population Description

This analysis was conducted using only data for patients that completed the baseline through week 8 time points.

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	71	35
Remains Elevated	23 30.7%	5 13.5%
Elevated to Normal	29 38.7%	11 29.7%
Remains Normal	16 21.3%	17 45.9%
Normal to Elevated	3 4%	2 5.4%

6. Secondary Outcome

Title	Changes in ALT
Description	This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up
Time Frame	From baseline to week 16

Outcome Measure Data

Analysis Population Description

This analysis was conducted using only data for patients that completed the baseline through week 16 time points.

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	68	31
Remains Elevated	12 16%	4 10.8%
Elevated to Normal	38 50.7%	11 29.7%
Remains Normal	17 22.7%	15 40.5%
Normal to Elevated	1 1.3%	1 2.7%

7. Secondary Outcome

Title	Changes in ALT
Description	This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame	From baseline to end of treatment

Outcome Measure Data

Analysis Population Description

This analysis was conducted using only data for patients that completed the baseline through end of treatment time points.

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	45	18
Remains Elevated	4 5.3%	3 8.1%
Elevated to Normal	28 37.3%	6 16.2%
Remains Normal	13 17.3%	9 24.3%
Normal to Elevated	0 0%	0 0%

8. Secondary Outcome

Title	Changes in ALT
Description	This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame	From baseline to end of follow up

Outcome Measure Data

Analysis Population Description

This analysis was conducted using only data for patients that completed the baseline through the end of follow-up time points.

Arm/Group Title	NTZ+PR	Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.	One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Measure Participants	45	18
Remains Elevated	9 12%	2 5.4%
Elevated to Normal	23 30.7%	7 18.9%
Remains Normal	13 17.3%	8 21.6%
Normal to Elevated	0 0%	1 2.7%

Adverse Events

Time Frame	1 year, 10 months
Arm/Group Title	NTZ+PR		Placebo+PR
Arm/Group Description	One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.		One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
All Cause Mortality
	NTZ+PR		Placebo+PR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NTZ+PR		Placebo+PR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/75 (16%)		7/37 (18.9%)
Blood and lymphatic system disorders
ANEMIA	1/75 (1.3%)	1	1/37 (2.7%)	1
Cardiac disorders
INFARCT MYOCARD	1/75 (1.3%)	1	0/37 (0%)	0
HEART ARREST	0/75 (0%)	0	1/37 (2.7%)	1
Eye disorders
RETINAL DIS	1/75 (1.3%)	1	0/37 (0%)	0
Gastrointestinal disorders
PAIN ABDO	1/75 (1.3%)	1	1/37 (2.7%)	1
DIARRHEA	1/75 (1.3%)	1	0/37 (0%)	0
GASTROENTERITIS	1/75 (1.3%)	1	0/37 (0%)	0
CONSTIP	1/75 (1.3%)	1	0/37 (0%)	0
HEM GI	1/75 (1.3%)	1	0/37 (0%)	0
General disorders
FEVER	0/75 (0%)	0	1/37 (2.7%)	1
ASTHENIA	1/75 (1.3%)	1	0/37 (0%)	0
Metabolism and nutrition disorders
DEHYDRAT	1/75 (1.3%)	1	0/37 (0%)	0
HYPOKALEM	1/75 (1.3%)	1	0/37 (0%)	0
HYPERKALEM	0/75 (0%)	0	1/37 (2.7%)	1
Musculoskeletal and connective tissue disorders
BONE FRACT SPONTAN	1/75 (1.3%)	1	0/37 (0%)	0
Nervous system disorders
SYNCOPE	1/75 (1.3%)	1	0/37 (0%)	0
EMOTION LABIL	0/75 (0%)	0	1/37 (2.7%)	1
Renal and urinary disorders
KIDNEY FAIL	1/75 (1.3%)	1	1/37 (2.7%)	1
Respiratory, thoracic and mediastinal disorders
DYSPNEA	3/75 (4%)	3	0/37 (0%)	0
PNEUMONIA	1/75 (1.3%)	1	4/37 (10.8%)	4
CARCINOMA LUNG	1/75 (1.3%)	1	0/37 (0%)	0
PNEUMONIA ASPIR	1/75 (1.3%)	1	0/37 (0%)	0
EFFUS PLEURAL	0/75 (0%)	0	1/37 (2.7%)	1
APNEA	0/75 (0%)	0	1/37 (2.7%)	1
Vascular disorders
HYPERTENS	0/75 (0%)	0	1/37 (2.7%)	1
Other (Not Including Serious) Adverse Events
	NTZ+PR		Placebo+PR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/75 (97.3%)		37/37 (100%)
Blood and lymphatic system disorders
Anemia	30/75 (40%)	30	11/37 (29.7%)	11
Leukopenia	16/75 (21.3%)	16	10/37 (27%)	10
Gastrointestinal disorders
Diarrhea	36/75 (48%)	36	8/37 (21.6%)	8
Nausea	32/75 (42.7%)	32	10/37 (27%)	10
Anorexia	21/75 (28%)	21	4/37 (10.8%)	4
Stomatitis Ulcer	10/75 (13.3%)	10	2/37 (5.4%)	2
Vomit	9/75 (12%)	9	1/37 (2.7%)	1
Constip	9/75 (12%)	9	5/37 (13.5%)	5
Dyspepsia	4/75 (5.3%)	4	6/37 (16.2%)	6
Pain Abdo	12/75 (16%)	12	6/37 (16.2%)	6
General disorders
Asthenia	52/75 (69.3%)	52	25/37 (67.6%)	25
Headache	26/75 (34.7%)	26	15/37 (40.5%)	15
Pain	22/75 (29.3%)	22	7/37 (18.9%)	7
Fever	15/75 (20%)	15	6/37 (16.2%)	6
Chills	11/75 (14.7%)	11	4/37 (10.8%)	4
Inject site react	9/75 (12%)	9	2/37 (5.4%)	2
Flu Synd	6/75 (8%)	6	4/37 (10.8%)	4
Metabolism and nutrition disorders
Weight dec	12/75 (16%)	12	6/37 (16.2%)	6
Hypercholesterem	0/75 (0%)	0	4/37 (10.8%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	14/75 (18.7%)	14	3/37 (8.1%)	3
Myalgia	11/75 (14.7%)	11	9/37 (24.3%)	9
Nervous system disorders
Insomnia	27/75 (36%)	27	10/37 (27%)	10
Nervousness	24/75 (32%)	24	6/37 (16.2%)	6
Depression	22/75 (29.3%)	22	9/37 (24.3%)	9
Thinking Abnorm	16/75 (21.3%)	16	6/37 (16.2%)	6
Dizziness	12/75 (16%)	12	6/37 (16.2%)	6
Emotion labil	10/75 (13.3%)	10	7/37 (18.9%)	7
Renal and urinary disorders
Urin Abnorm	32/75 (42.7%)	32	2/37 (5.4%)	2
Respiratory, thoracic and mediastinal disorders
Dyspnea	31/75 (41.3%)	31	12/37 (32.4%)	12
Pharyngitis	13/75 (17.3%)	13	8/37 (21.6%)	8
Cough inc	12/75 (16%)	12	4/37 (10.8%)	4
Rhinitis	11/75 (14.7%)	11	3/37 (8.1%)	3
Pneumonia	2/75 (2.7%)	2	5/37 (13.5%)	5
Skin and subcutaneous tissue disorders
Rash	37/75 (49.3%)	37	11/37 (29.7%)	11
Pruritis	24/75 (32%)	24	8/37 (21.6%)	8
Skin dry	21/75 (28%)	21	6/37 (16.2%)	6
Alopecia	19/75 (25.3%)	19	3/37 (8.1%)	3
Vascular disorders
Hypertens	0/75 (0%)	0	4/37 (10.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Presentation and/or publication is encouraged provided the Sponsor is notified in advance and given the opportunity to review the manuscript or abstract 30 days prior to its submission for presentation at a scientific meeting or for publication in a scientific journal. The investigators will have complete autonomy regarding the content and wording including the decision of whether or not to publish.