Study of Nitazoxanide, Peginterferon Alfa-2a and Ribaviri... | NCT00637923

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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 Biological: Peginterferon alfa-2a Drug: Ribavirin
2	Placebo Comparator	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 Biological: Peginterferon alfa-2a Drug: Ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug	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.

Measure	Description	Time Frame
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)	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.	24 weeks after end of treatment

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

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Emmet B Keeffe, MD, MACP	Romark Laboratories L.C.	Study Director
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

Facility	Status	City	State	ZIP	Country	Contacts
Palo Alto VA Healthcare System		Palo Alto	California	94304	United States
Yale University School of Medicine

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	NTZ+PR	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.
FG001	Placebo+PR

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	NTZ+PR	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.
BG001	Placebo+PR	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00075 BG00137 BG002112

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)

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.

Posted

Number

participants

24 weeks after end of treatment

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG00075 OG00137

Title

Denominators

Categories

Responders

Title	Measurements
	OG00032 OG00113

Non-responders

Title	Measurements
	OG000

Secondary

End of Treatment Response (HCV RNA Below Lower Limit of Detection)

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

Posted

Number

participants

At end of treatment

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Secondary

Early Virologic Response (HCV RNA Below Lower Limit of Detection)

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

Posted

Number

participants

After 12 weeks combination treatment

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Secondary

Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)

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

Posted

Number

participants

After 4 weeks combination treatment

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Secondary

Changes in ALT

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.

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

Posted

Number

participants

From baseline to week 8

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Secondary

Changes in ALT

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

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

Posted

Number

participants

From baseline to week 16

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Secondary

Changes in ALT

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.

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

Posted

Number

participants

From baseline to end of treatment

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Secondary

Changes in ALT

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.

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

Posted

Number

participants

From baseline to end of follow up

ID	Title	Description
OG000	NTZ+PR	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.
OG001	Placebo+PR	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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PAIN ABDO	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0011 events1 affected37 at risk
DIARRHEA	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0003 events3 affected75 at risk EG0010 events0 affected37 at risk
ANEMIA	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0011 events1 affected37 at risk
PNEUMONIA	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0014 events4 affected37 at risk
RETINAL DIS	Eye disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
CARCINOMA LUNG	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
GASTROENTERITIS	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
PNEUMONIA ASPIR	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
INFARCT MYOCARD	Cardiac disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
KIDNEY FAIL	Renal and urinary disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0011 events1 affected37 at risk
DEHYDRAT	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
CONSTIP	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
SYNCOPE	Nervous system disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
BONE FRACT SPONTAN	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
HYPOKALEM	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
HEM GI	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk
HYPERTENS	Vascular disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
FEVER	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
EFFUS PLEURAL	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
APNEA	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
HEART ARREST	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
EMOTION LABIL	Nervous system disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
HYPERKALEM	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0011 events1 affected37 at risk
ASTHENIA	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected75 at risk EG0010 events0 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00036 events36 affected75 at risk EG0018 events8 affected37 at risk
Nausea	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00032 events32 affected75 at risk EG00110 events10 affected37 at risk
Anorexia	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00021 events21 affected75 at risk EG0014 events4 affected37 at risk
Stomatitis Ulcer	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00010 events10 affected75 at risk EG0012 events2 affected37 at risk
Vomit	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0009 events9 affected75 at risk EG0011 events1 affected37 at risk
Constip	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0009 events9 affected75 at risk EG0015 events5 affected37 at risk
Dyspepsia	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0004 events4 affected75 at risk EG0016 events6 affected37 at risk
Asthenia	General disorders	COSTART	Systematic Assessment	EG00052 events52 affected75 at risk EG00125 events25 affected37 at risk
Headache	General disorders	COSTART	Systematic Assessment	EG00026 events26 affected75 at risk EG00115 events15 affected37 at risk
Pain	General disorders	COSTART	Systematic Assessment	EG00022 events22 affected75 at risk EG0017 events7 affected37 at risk
Fever	General disorders	COSTART	Systematic Assessment	EG00015 events15 affected75 at risk EG0016 events6 affected37 at risk
Pain Abdo	Gastrointestinal disorders	COSTART	Systematic Assessment	EG00012 events12 affected75 at risk EG0016 events6 affected37 at risk
Chills	General disorders	COSTART	Systematic Assessment	EG00011 events11 affected75 at risk EG0014 events4 affected37 at risk
Inject site react	General disorders	COSTART	Systematic Assessment	EG0009 events9 affected75 at risk EG0012 events2 affected37 at risk
Flu Synd	General disorders	COSTART	Systematic Assessment	EG0006 events6 affected75 at risk EG0014 events4 affected37 at risk
Insomnia	Nervous system disorders	COSTART	Systematic Assessment	EG00027 events27 affected75 at risk EG00110 events10 affected37 at risk
Nervousness	Nervous system disorders	COSTART	Systematic Assessment	EG00024 events24 affected75 at risk EG0016 events6 affected37 at risk
Depression	Nervous system disorders	COSTART	Systematic Assessment	EG00022 events22 affected75 at risk EG0019 events9 affected37 at risk
Thinking Abnorm	Nervous system disorders	COSTART	Systematic Assessment	EG00016 events16 affected75 at risk EG0016 events6 affected37 at risk
Dizziness	Nervous system disorders	COSTART	Systematic Assessment	EG00012 events12 affected75 at risk EG0016 events6 affected37 at risk
Emotion labil	Nervous system disorders	COSTART	Systematic Assessment	EG00010 events10 affected75 at risk EG0017 events7 affected37 at risk
Rash	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG00037 events37 affected75 at risk EG00111 events11 affected37 at risk
Pruritis	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG00024 events24 affected75 at risk EG0018 events8 affected37 at risk
Skin dry	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG00021 events21 affected75 at risk EG0016 events6 affected37 at risk
Alopecia	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG00019 events19 affected75 at risk EG0013 events3 affected37 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG00031 events31 affected75 at risk EG00112 events12 affected37 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG00013 events13 affected75 at risk EG0018 events8 affected37 at risk
Cough inc	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG00012 events12 affected75 at risk EG0014 events4 affected37 at risk
Rhinitis	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG00011 events11 affected75 at risk EG0013 events3 affected37 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0002 events2 affected75 at risk EG0015 events5 affected37 at risk
Urin Abnorm	Renal and urinary disorders	COSTART	Systematic Assessment	EG00032 events32 affected75 at risk EG0012 events2 affected37 at risk
Anemia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG00030 events30 affected75 at risk EG00111 events11 affected37 at risk
Leukopenia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG00016 events16 affected75 at risk EG00110 events10 affected37 at risk
Weight dec	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG00012 events12 affected75 at risk EG0016 events6 affected37 at risk
Hypercholesterem	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0014 events4 affected37 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG00014 events14 affected75 at risk EG0013 events3 affected37 at risk
Myalgia	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG00011 events11 affected75 at risk EG0019 events9 affected37 at risk
Hypertens	Vascular disorders	COSTART	Systematic Assessment	EG0000 events0 affected75 at risk EG0014 events4 affected37 at risk

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NTZ+PR	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.			12	75	73	75
EG001	Placebo+PR	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.			7	37	37	37

ID	Term
C041747	nitazoxanide
C100416	peginterferon alfa-2a
D012254	Ribavirin