4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Nitazoxanide; Biological: Peginterferon alfa-2a

• Registration Number: NCT00763568
• Lead Sponsor: Romark Laboratories L.C.

Brief Summary

The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Last Update Submitted: 2008-09-26
• Study First Posted: 2008-10-01
• Last Update Posted: 2008-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Chronic hepatitis C

Exclusion Criteria

• Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
• Unable to take oral medication.
• Females who are either pregnant, breast-feeding or not using birth control.
• Males whose female partners are pregnant or plan to become pregnant.
• Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
• Patients with HIV, HAV, HBV or HDV.
• Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
• Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
• History of hypersensitivity or intolerance to nitazoxanide or peginterferon.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitazoxanide	Nitazoxanide	One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Nitazoxanide	Peginterferon alfa-2a	One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

Primary Outcome Measures

Name	Time	Method
Sustained virologic response	24 weeks after the end of treatment

Secondary Outcome Measures

Name	Time	Method
End of treatment virologic response	At the end of treatment
Early virologic response	After 12 weeks of combination therapy
Rapid virologic response	After 4 weeks of combination therapy
ALT normalization	24 weeks after the end of treatment

Trial Locations

Locations (1)

Digestive Disease Center; 🇪🇬 Tanta, Egypt