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Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C (STEALTHC-2)

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nitazoxanide

Placebo

Peginterferon alfa-2a

Ribavirin

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic hepatitis C genotype 1.
Failed to respond to ≥12 weeks of peginterferon and ribavirin (<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24).

Exclusion Criteria:

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 antigen 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) >28.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00495391

First Posted

July 2, 2007

Last Updated

April 8, 2014

Sponsor

Romark Laboratories L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00495391

Brief Title

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

Acronym

STEALTHC-2

Official Title

Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Patients With Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Romark Laboratories L.C.

4. Oversight

Data Monitoring Committee

Yes

5. 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 patients that have previously failed to respond to treatment with peginterferon and ribavirin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

Other Intervention Name(s)

Alinia

Intervention Description

One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One oral placebo tablet twice daily for 52 weeks.

Intervention Type

Biological

Intervention Name(s)

Peginterferon alfa-2a

Other Intervention Name(s)

PEGASYS

Intervention Description

Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Other Intervention Name(s)

COPEGUS

Intervention Description

1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

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

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

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

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

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic hepatitis C genotype 1. Failed to respond to ≥12 weeks of peginterferon and ribavirin (<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24). Exclusion Criteria: 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 antigen 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) >28. 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.

Overall Study Officials: