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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763568
• Other study ID #: RM01-3037
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2008
• Last updated: September 26, 2008
• Start date: August 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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.

Biological:
• 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.

Locations

Country	Name	City	State
Egypt	Digestive Disease Center	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response		24 weeks after the end of treatment	No
Secondary	End of treatment virologic response		At the end of treatment	No
Secondary	Early virologic response		After 12 weeks of combination therapy	No
Secondary	Rapid virologic response		After 4 weeks of combination therapy	No
Secondary	ALT normalization		24 weeks after the end of treatment	No