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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:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00763568
First received: September 26, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • End of treatment virologic response [ Time Frame: At the end of treatment ] [ Designated as safety issue: No ]
  • Early virologic response [ Time Frame: After 12 weeks of combination therapy ] [ Designated as safety issue: No ]
  • Rapid virologic response [ Time Frame: After 4 weeks of combination therapy ] [ Designated as safety issue: No ]
  • ALT normalization [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT00763568     History of Changes
Other Study ID Numbers: RM01-3037
Study First Received: September 26, 2008
Last Updated: September 26, 2008
Health Authority: Egypt: Ministry of Health and Population

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

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

ClinicalTrials.gov processed this record on May 23, 2013