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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00763568

Enrollment

Registered

2008-10-01

Start date

2006-08-31

Completion date

2008-09-30

Last updated

2008-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C, Viral hepatitis

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.

Interventions

DRUGNitazoxanide

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.

BIOLOGICALPeginterferon 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Sustained virologic response	24 weeks after the end of treatment

Secondary

Measure	Time frame
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026