Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C (STEALTHC-1)

Romark Laboratories

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Biological: Peginterferon alfa-2a; Drug: Ribavirin; Drug: Nitazoxanide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421434

RM01-3036

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 3 patient groups

Nitazoxanide-Peginterferon

Experimental group

Description:

One oral nitazoxanide 500 mg tablet with food twice daily for 12 weeks followed by 36 weeks of one oral nitazoxanide 500 mg tablet plus weekly injections of 180 µg peginterferon alfa-2a.

Treatment:

Biological: Peginterferon alfa-2a

Drug: Nitazoxanide

Biological: Peginterferon alfa-2a

Nitazoxanide-Peginterferon-Ribavirin

Experimental group

Description:

One oral nitazoxanide 500 mg tablet with food twice daily for 12 weeks followed by 36 weeks of one oral nitazoxanide 500 mg tablet plus weekly injections of 180 µg peginterferon alfa-2a plus oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses.

Treatment:

Biological: Peginterferon alfa-2a

Drug: Ribavirin

Drug: Nitazoxanide

Biological: Peginterferon alfa-2a

Drug: Ribavirin

Peginterferon-Ribavirin

Active Comparator group

Description:

Weekly injections of 180 µg peginterferon alfa-2a plus oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.

Treatment:

Biological: Peginterferon alfa-2a

Drug: Ribavirin

Biological: Peginterferon alfa-2a

Drug: Ribavirin