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

NCT00763568 | Completed Phase 2

• 1 other identifier: RM01-3037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Viral hepatitis

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 (1)

Nitazoxanide

EXPERIMENTAL

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; Biological: Peginterferon alfa-2a

Interventions

Nitazoxanide DRUG

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.

Also known as: Alinia

Nitazoxanide

Peginterferon alfa-2a BIOLOGICAL

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.

Also known as: PEGASYS

Nitazoxanide

Eligibility Criteria

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

You may qualify if:

• Chronic hepatitis C

You may not qualify if:

• 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.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (1)

Digestive Disease Center

Tanta, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

nitazoxanide; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; 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

Study Officials

• Asem Elfert, MD

  Tanta University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: October 1, 2008
• Study Start: August 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 1, 2008

Record last verified: 2008-09

Locations

EG (1)