Chronic Hepatitis CPhase 2NCT00418054
Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C
A Phase 2 study testing Nitazoxanide plus peginterferon alfa-2b and Peginterferon alfa-2b in people with Chronic Hepatitis C, run by Romark Laboratories L.C. at 2 sites in Egypt.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C. 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 plus peginterferon alfa-2b and Peginterferon alfa-2b
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2005to Jul 2006
- 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
- 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.
- Patients that have not previously received peginterferon.
Who cannot join
- Patients unable to take oral medications.
- Use of ribavirin within 30 days prior to enrollment.
- Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027.
- Patients with other causes of liver disease.
- Transplant recipients receiving immune suppression therapy.
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- Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay.
- Patients with decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores >6.
- Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of >20 grams per day.
- Patients who are clinically unstable.
- 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 or peginterferon alfa-2b solution for injection.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta
About this study
Official title: Phase II, Multi-Center, Randomized, Double-Blind Study of Nitazoxanide Tablets Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Chronic Hepatitis C
The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.
- Conditions
- Chronic Hepatitis C
- Being tested
- Nitazoxanide plus peginterferon alfa-2b, Peginterferon alfa-2b
- 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.
Nitazoxanide plus peginterferon alfa-2bDrug
Peginterferon alfa-2bDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic response
Secondary outcomes (2)
2 log drop in serum HCV RNA
Change in ALT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startDec 2005
- Study completionJul 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yehia El-Gohary, MD, Principal investigator, Department of Tropical Medicine & Infectious Diseases, Alexandria UniversityAsem Elfert, MD, Principal investigator, Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418054
- Sponsor's protocol ID
- RM01-2022
- Status last verified
- Jan 2007
- First submitted
- 3 Jan 2007
- Last updated
- 4 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multi-Center, Randomized, Double-Blind Study of Nitazoxanide Tablets Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00418054
- Acronym / sponsor ID
- RM01-2022
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jul 2006
- First posted
- 4 Jan 2007 (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 evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients that have not previously received peginterferon.
Key exclusion criteria (12 listed)
- Patients unable to take oral medications.
- Use of ribavirin within 30 days prior to enrollment.
- Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027.
- Patients with other causes of 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 |
|---|---|---|
| Nitazoxanide plus peginterferon alfa-2b | Drug | – |
| Peginterferon alfa-2b | Drug | – |
Primary outcome
Virologic response
2 secondary outcomes
2 log drop in serum HCV RNA
Change in ALT
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 4 Jan 2007.
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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.
Yehia El-Gohary, MD principal investigator
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Asem Elfert, MD principal investigator
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
2 sites 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 plus peginterferon alfa-2b and Peginterferon alfa-2b in people with Chronic Hepatitis C, run by Romark Laboratories L.C. at 2 sites 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 5 inclusion and 12 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 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Virologic response. 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 4 Jan 2007.