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

Information source: Romark Laboratories L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Nitazoxanide (Drug); Peginterferon alfa-2a (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Romark Laboratories L.C.

Official(s) and/or principal investigator(s):
Asem Elfert, MD, Principal Investigator, Affiliation: Tanta University School of Medicine


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.

Clinical Details

Official title: Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sustained virologic response

Secondary outcome:

End of treatment virologic response

Early virologic response

Rapid virologic response

ALT normalization


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- History of hypersensitivity or intolerance to nitazoxanide or peginterferon.

Locations and Contacts

Digestive Disease Center, Tanta, Egypt
Additional Information

Starting date: August 2006
Last updated: September 26, 2008

Page last updated: August 23, 2015

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