Clinical trial NCT00418054: Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C
Official title: Phase II, Multi-Center, Randomized, Double-Blind Study of Nitazoxanide Tablets Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 40
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 alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.


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.
* Patients that have not previously received peginterferon.

Exclusion Criteria:

* Patients unable to take oral medications.
* Use of ribavirin within 30 days prior to enrollment.
* Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027.
* Patients with other causes of liver disease.
* Transplant recipients receiving immune suppression therapy.
* Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay.
* Patients with decompensated cirrhosis, thrombocytopenia (platelet count \<80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores \>6.
* Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of \>20 grams per day.
* Patients who are clinically unstable.
* 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 or peginterferon alfa-2b solution for injection.

Primary outcomes:
measure: Virologic response
Secondary outcomes:
measure: 2 log drop in serum HCV RNA
measure: Change in ALT
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: