Chronic Hepatitis CPhase 2NCT00763568
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
A Phase 2 study testing Nitazoxanide and Peginterferon alfa-2a in people with Chronic Hepatitis C, run by Romark Laboratories L.C. at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Nitazoxanide and Peginterferon alfa-2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2006to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Nitazoxanide, Peginterferon alfa-2a
- Keywords
- Chronic hepatitis C, Viral hepatitis
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia
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.
Peginterferon alfa-2aBiological
Also called PEGASYS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nitazoxanide; Biological: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response
Measured: 24 weeks after the end of treatment
Secondary outcomes (4)
End of treatment virologic response
Measured: At the end of treatment
Early virologic response
Measured: After 12 weeks of combination therapy
Rapid virologic response
Measured: After 4 weeks of combination therapy
ALT normalization
Measured: 24 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Asem Elfert, MD, Principal investigator, Tanta University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763568
- Sponsor's protocol ID
- RM01-3037
- Status last verified
- Sep 2008
- First submitted
- 26 Sep 2008
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00763568
- Acronym / sponsor ID
- RM01-3037
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Viral hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Experimental | Drug: Nitazoxanide, Biological: Peginterferon alfa-2aOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hepatitis C
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: AliniaOne 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 |
| Peginterferon alfa-2aAlso: PEGASYSOne 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. | Biological | Nitazoxanide |
Primary outcome
Sustained virologic response
Time frame: 24 weeks after the end of treatment
4 secondary outcomes
End of treatment virologic response
Time frame: At the end of treatment
Early virologic response
Time frame: After 12 weeks of combination therapy
Rapid virologic response
Time frame: After 4 weeks of combination therapy
ALT normalization
Time frame: 24 weeks after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asem Elfert, MD principal investigator
Tanta University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide and Peginterferon alfa-2a in people with Chronic Hepatitis C, run by Romark Laboratories L.C. at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virologic response (time frame: 24 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2008.