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4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763568
First Posted: October 1, 2008
Last Update Posted: October 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Romark Laboratories L.C.
  Purpose
The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.

Condition Intervention Phase
Chronic Hepatitis C Drug: Nitazoxanide Biological: Peginterferon alfa-2a Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Sustained virologic response [ Time Frame: 24 weeks after the end of treatment ]

Secondary Outcome Measures:
  • End of treatment virologic response [ Time Frame: At the end of treatment ]
  • Early virologic response [ Time Frame: After 12 weeks of combination therapy ]
  • Rapid virologic response [ Time Frame: After 4 weeks of combination therapy ]
  • ALT normalization [ Time Frame: 24 weeks after the end of treatment ]

Enrollment: 40
Study Start Date: August 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitazoxanide
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Drug: Nitazoxanide
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Name: Alinia
Biological: Peginterferon alfa-2a
One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Name: PEGASYS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C

Exclusion Criteria:

  • Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
  • Unable to take oral medication.
  • Females who are either pregnant, breast-feeding or not using birth control.
  • Males whose female partners are pregnant or plan to become pregnant.
  • Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
  • Patients with HIV, HAV, HBV or HDV.
  • Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
  • Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
  • History of hypersensitivity or intolerance to nitazoxanide or peginterferon.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763568


Locations
Egypt
Digestive Disease Center
Tanta, Egypt
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: Asem Elfert, MD Tanta University School of Medicine
  More Information

Responsible Party: Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT00763568     History of Changes
Other Study ID Numbers: RM01-3037
First Submitted: September 26, 2008
First Posted: October 1, 2008
Last Update Posted: October 1, 2008
Last Verified: September 2008

Keywords provided by Romark Laboratories L.C.:
Chronic hepatitis C
Viral hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Interferon-alpha
Nitazoxanide
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antiparasitic Agents