Clinical trial NCT00421434: Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Official title: Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2007-01-12
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sustained virologic response
timeFrame: 24 weeks after the end of treatment
Secondary outcomes:
measure: End of treatment virologic response
timeFrame: At the end of treatment
measure: Early virologic response
timeFrame: After 12 weeks of combination therapy
measure: Rapid virologic response
timeFrame: After 4 weeks of combination therapy
measure: ALT normalization
timeFrame: 24 weeks after the end of treatment
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Department of Tropical Medicine & Infectious Diseases, Alexandria University
city: Tanta
country: Egypt
facility: Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Study officials:
affiliation: Department of Tropical Medicine & Infectious Diseases, Alexandria University
name: Yehia El-Gohary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
name: Asem Elfert, MD
role: PRINCIPAL_INVESTIGATOR
References: