Chronic Hepatitis CPhase 2/3STEALTHC-1NCT00421434
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
A Phase 2/3 study testing Nitazoxanide, Peginterferon alfa-2a and Ribavirin 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 and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. 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, Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2006to Sep 2008
- Phase
- Phase 2/3
- 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.
Who cannot join
- 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.
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- 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.
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: Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C
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.
- Conditions
- Chronic Hepatitis C
- Being tested
- Nitazoxanide, Peginterferon alfa-2a, Ribavirin
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Peginterferon alfa-2aBiological
Also called PEGASYS
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Peginterferon alfa-2aBiological
Also called PEGASYS
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
RibavirinDrug
Also called COPEGUS
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
RibavirinDrug
Also called COPEGUS
Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide-Peginterferon | Experimental | 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. Receives: Drug: Nitazoxanide; Biological: Peginterferon alfa-2a |
| Nitazoxanide-Peginterferon-Ribavirin | Experimental | 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. Receives: Drug: Nitazoxanide; Biological: Peginterferon alfa-2a; Drug: Ribavirin |
| Peginterferon-Ribavirin | Active comparator | 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. Receives: Biological: Peginterferon alfa-2a; Drug: Ribavirin |
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 posted12 Jan 2007 (estimated)
- Study startJun 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
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
- NCT00421434
- Sponsor's protocol ID
- RM01-3036
- Acronym
- STEALTHC-1
- Status last verified
- Sep 2008
- First submitted
- 10 Jan 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00421434
- Acronym / sponsor ID
- STEALTHC-1 / RM01-3036
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide-Peginterferon | Experimental | Drug: Nitazoxanide, Biological: Peginterferon alfa-2aOne 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. |
| Nitazoxanide-Peginterferon-Ribavirin | Experimental | Drug: Nitazoxanide, Biological: Peginterferon alfa-2a, Drug: RibavirinOne 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. |
| Peginterferon-Ribavirin | Active comparator | Biological: Peginterferon alfa-2a, Drug: RibavirinWeekly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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.
Key exclusion criteria (9 listed)
- 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.
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 oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks. | Drug | Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin |
| Peginterferon alfa-2aAlso: PEGASYSWeekly injections of 180µg peginterferon alfa-2a for 36 weeks. | Biological | Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin |
| Peginterferon alfa-2aAlso: PEGASYSWeekly injections of 180 µg peginterferon alfa-2a for 48 weeks. | Biological | Peginterferon-Ribavirin |
| RibavirinAlso: COPEGUSOral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks. | Drug | Nitazoxanide-Peginterferon-Ribavirin |
| RibavirinAlso: COPEGUSOral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks. | Drug | Peginterferon-Ribavirin |
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 25 Sep 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.
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 2/3 study testing Nitazoxanide, Peginterferon alfa-2a and Ribavirin 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 4 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 25 Sep 2008. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Sep 2008.