Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C (STEALTHC-1)

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00421434
First received: January 10, 2007
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Nitazoxanide
Biological: Peginterferon alfa-2a
Drug: Ribavirin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin 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: 121
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitazoxanide-Peginterferon
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
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Other Name: Alinia
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Name: PEGASYS
Experimental: Nitazoxanide-Peginterferon-Ribavirin
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
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Other Name: Alinia
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Other Name: PEGASYS
Drug: Ribavirin
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
Other Name: COPEGUS
Active Comparator: Peginterferon-Ribavirin
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
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Other Name: PEGASYS
Drug: Ribavirin
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.
Other Name: COPEGUS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421434

Locations
Egypt
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria, Egypt
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta, Egypt
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT00421434     History of Changes
Other Study ID Numbers: RM01-3036
Study First Received: January 10, 2007
Last Updated: September 23, 2008
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Romark Laboratories L.C.:
Hepatitis C

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
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Nitazoxanide
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiparasitic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014