Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

— STEALTHC-1  

Official title:

Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421434
• Other study ID #: RM01-3036
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2007
• Last updated: September 23, 2008
• Start date: June 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 evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• 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:

• Age =18 years.

• Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.

• Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.

• HCV genotype 4.

Exclusion Criteria:

• Patients who have previously failed to respond to =12 weeks of peginterferon-ribavirin combination therapy.

• Females who are either pregnant, breast-feeding or not using birth control and are sexually active.

• Males whose female partners are pregnant.

• Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).

• Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.

• Patients with a history of alcoholism or with an alcohol consumption of >40 grams per day.

• Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).

• Patients with any concomitant condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.

• History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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 oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.

Biological:
• Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
• Peginterferon alfa-2a
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.

Drug:
• Ribavirin
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =75 kg) daily in two divided doses for 36 weeks.
• Ribavirin
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =75 kg) daily in two divided doses for 48 weeks.

Locations

Country	Name	City	State
Egypt	Department of Tropical Medicine & Infectious Diseases, Alexandria University	Alexandria
Egypt	Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine	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