CClinicalTrials.gg
Sign In
CompletedNCT00763568Updated Oct 1, 2008

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

A Phase 2 interventional study of Nitazoxanide and Peginterferon alfa-2a in Chronic Hepatitis C, sponsored by Romark Laboratories L.C.. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-01.

Sponsored by Romark Laboratories L.C. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • Chronic hepatitis C
  • Viral hepatitis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Romark Laboratories L.C. is the lead sponsor of 29 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic hepatitis C

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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 · Biological: Peginterferon alfa-2a

Interventions

  • DrugNitazoxanide

    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

  • BiologicalPeginterferon 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.

    Also known as: PEGASYS

06

What researchers measure

Primary outcomes

  1. Sustained virologic response

    Time frame: 24 weeks after the end of treatment

Secondary outcomes

  1. End of treatment virologic response

    Time frame: At the end of treatment

  2. Early virologic response

    Time frame: After 12 weeks of combination therapy

  3. Rapid virologic response

    Time frame: After 4 weeks of combination therapy

  4. ALT normalization

    Time frame: 24 weeks after the end of treatment

07

Study locations

1 site
  • Digestive Disease Center
    Tanta, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00763568
Lead sponsor
Romark Laboratories L.C.
First posted
Oct 1, 2008
Start date
Aug 2006
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Oct 1, 2008

Study contacts

Asem Elfert, MD
principal investigator · Tanta University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Romark Laboratories L.C.

Start the discussion