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

NCT00421434 | Completed Phase 2

• 1 other identifier: RM01-3036
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response

  24 weeks after the end of treatment

Secondary Outcomes (4)

• End of treatment virologic response

  At the end of treatment

• Early virologic response

  After 12 weeks of combination therapy

• Rapid virologic response

  After 4 weeks of combination therapy

• ALT normalization

  24 weeks after the end of treatment

Study Arms (3)

Nitazoxanide-Peginterferon

EXPERIMENTAL

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.

Drug: Nitazoxanide; Biological: Peginterferon alfa-2a

Nitazoxanide-Peginterferon-Ribavirin

EXPERIMENTAL

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.

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

Peginterferon-Ribavirin

ACTIVE COMPARATOR

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.

Biological: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Nitazoxanide DRUG

One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.

Also known as: Alinia

Nitazoxanide-Peginterferon; Nitazoxanide-Peginterferon-Ribavirin

Peginterferon alfa-2a BIOLOGICAL

Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

Also known as: PEGASYS

Nitazoxanide-Peginterferon; Nitazoxanide-Peginterferon-Ribavirin

Ribavirin DRUG

Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.

Also known as: COPEGUS

Nitazoxanide-Peginterferon-Ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (2)

Department of Tropical Medicine & Infectious Diseases, Alexandria University

Alexandria, Egypt

Location

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

nitazoxanide; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yehia El-Gohary, MD

  Department of Tropical Medicine & Infectious Diseases, Alexandria University

  PRINCIPAL INVESTIGATOR

• Asem Elfert, MD

  Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 12, 2007
• Study Start: June 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

EG (2)