Chronic Hepatitis CPhase 2STEALTHC-3NCT00637923
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
A Phase 2 study testing Nitazoxanide, Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by Romark Laboratories L.C. at 10 sites in United States.
Trial summary
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients. 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?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2008to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 genotype 1.
Who cannot join
- Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.
- Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
- Other causes of liver disease including autoimmune hepatitis.
- Transplant recipients receiving immune suppression therapy.
- Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
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- Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score >6 or Model for End-stage Liver Disease (MELD) score >8.
- Alcohol consumption of >40 grams per day or an alcohol use pattern that will interfere with the study.
- Absolute neutrophil count <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
- Hypothyroidism or hyperthyroidism not effectively treated with medication.
- Hemoglobin A1C (HgbA1c) >7.5 or history of diabetes mellitus.
- Body Mass Index (BMI) >34.
- History or other clinical evidence of significant or unstable cardiac disease.
- History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
- Serious or severe bacterial infection(s).
- Ulcerative or hemorrhagic/ischemic colitis.
- Pancreatitis.
- History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
- History of uncontrolled severe seizure disorder.
- Requires concomitant theophylline or methadone.
- History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
- History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
- Hemoglobinopathies.
- History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Metropolitan Research
Fairfax, Virginia, 22031
Florida Center for Gastroenterology
Largo, Florida, 33777
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Yale University School of Medicine
New Haven, Connecticut, 06520
New York Presbyterian-Weill Medical College of Cornell University
New York, New York, 10021
Palo Alto VA Healthcare System
Palo Alto, California, 94304
About this study
Official title: Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.
- Conditions
- Chronic Hepatitis C
- Being tested
- Nitazoxanide, Placebo, Peginterferon alfa-2a, Ribavirin
- Keywords
- Hepatitis C, Chronic
- 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 with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
PlaceboDrug
One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
Peginterferon alfa-2aBiological
Also called PEGASYS
One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
RibavirinDrug
Also called COPEGUS
Weight-based ribavirin for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. Receives: Drug: Nitazoxanide; Biological: Peginterferon alfa-2a; Drug: Ribavirin |
| 2 | Placebo comparator | One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. Receives: Drug: Placebo; 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 (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Measured: 24 weeks after end of treatment
Secondary outcomes (7)
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Measured: At end of treatment
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Measured: After 12 weeks combination treatment
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Measured: After 4 weeks combination treatment
Changes in ALT
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Measured: From baseline to week 8
Changes in ALT
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up
Measured: From baseline to week 16
Changes in ALT
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Measured: From baseline to end of treatment
Changes in ALT
This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Measured: From baseline to end of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmet B Keeffe, MD, MACP, Study director, Romark Laboratories L.C.Norman Gitlin, MD, Principal investigator, Atlanta Gastroenterology AssociatesJoseph K Lim, MD, Principal investigator, Yale UniversityIra Jacobson, MD, Principal investigator, New York Presbyterial-Weill Medical College of Cornell UniversityMitchell L Shiffman, MD, Principal investigator, McGuire Veteran's Administration Medical CenterRonald E Pruitt, MD, Principal investigator, Nashville Medical Research InstituteArthur Berman, DO, Principal investigator, Florida Center for GastroenterologyBruce Bacon, MD, Principal investigator, St. Louis University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637923
- Sponsor's protocol ID
- RM01-2026
- Acronym
- STEALTHC-3
- Status last verified
- Jan 2014
- First submitted
- 11 Mar 2008
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C
- ClinicalTrials.gov ID
- NCT00637923
- Acronym / sponsor ID
- STEALTHC-3 / RM01-2026
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Posted 6 Jan 2014
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 nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nitazoxanide, Biological: Peginterferon alfa-2a, Drug: RibavirinOne nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. |
| 2 | Placebo comparator | Drug: Placebo, Biological: Peginterferon alfa-2a, Drug: RibavirinOne placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin 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 (1 listed)
- Chronic hepatitis C genotype 1.
Key exclusion criteria (24 listed)
- Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.
- Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
- Other causes of liver disease including autoimmune hepatitis.
- Transplant recipients receiving immune suppression therapy.
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 with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. | Drug | 1 |
| PlaceboOne placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. | Drug | 2 |
| Peginterferon alfa-2aAlso: PEGASYSOne weekly injection of 180µg of peginterferon α-2a for 48 weeks. | Biological | 1, 2 |
| RibavirinAlso: COPEGUSWeight-based ribavirin for 48 weeks. | Drug | 1, 2 |
Primary outcome
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Time frame: 24 weeks after end of treatment
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
7 secondary outcomes
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Time frame: At end of treatment
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Time frame: After 12 weeks combination treatment
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Time frame: After 4 weeks combination treatment
Changes in ALT
Time frame: From baseline to week 8
Changes in ALT
Time frame: From baseline to week 16
Changes in ALT
Time frame: From baseline to end of treatment
Changes in ALT
Time frame: From baseline to end of follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emmet B Keeffe, MD, MACP study director
Romark Laboratories L.C.
Norman Gitlin, MD principal investigator
Atlanta Gastroenterology Associates
Joseph K Lim, MD principal investigator
Yale University
10 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, Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by Romark Laboratories L.C. at 10 sites in United States.
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 24 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (HCV RNA Below Lower Limit of Detection) (time frame: 24 weeks after 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 10 Feb 2014.