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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014