Chronic Hepatitis CPhase 3NCT00299936
Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects
A Phase 3 study testing Ribavirin, PEG-Intron in people with Chronic Hepatitis C, run by Weill Medical College of Cornell University.
Trial summary
The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Ribavirin, PEG-Intron
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.
About this study
Official title: Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects
The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects
Read the detailed description
Primary Objective:
This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms:
Treatment Arm A:
PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day
OR
Treatment Arm B:
PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day
Arm A \& Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.
- Conditions
- Chronic Hepatitis C
- Being tested
- Ribavirin, PEG-Intron
- Keywords
- hepatitis C, chronic hepatitis C, ribavirin, WIN-R
- 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.
Ribavirin, PEG-IntronDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Ira M Jacobson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299936
- Sponsor's protocol ID
- P02314
- Other IDs
- WIN-R
- Status last verified
- Mar 2006
- First submitted
- 3 Mar 2006
- Last updated
- 7 Mar 2006
- Results posted
- No
Publications
Hu KQ, Freilich B, Brown RS, Brass C, Jacobson IM. Impact of Hispanic or Asian ethnicity on the treatment outcomes of chronic hepatitis C: results from the WIN-R trial. J Clin Gastroenterol. 2011 Sep;45(8):720-6. doi: 10.1097/MCG.0b013e31820d35e3.
PubMed 21836471Jacobson IM, Brown RS Jr, McCone J, Black M, Albert C, Dragutsky MS, Siddiqui FA, Hargrave T, Kwo PY, Lambiase L, Galler GW, Araya V, Freilich B, Harvey J, Griffel LH, Brass CA; WIN-R Study Group. Impact of weight-based ribavirin with peginterferon alfa-2b in African Americans with hepatitis C virus genotype 1. Hepatology. 2007 Oct;46(4):982-90. doi: 10.1002/hep.21670.
PubMed 17894323Jacobson IM, Brown RS Jr, Freilich B, Afdhal N, Kwo PY, Santoro J, Becker S, Wakil AE, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Pauly MP, Mukhopadhyay P, Griffel LH, Brass CA; WIN-R Study Group. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. Hepatology. 2007 Oct;46(4):971-81. doi: 10.1002/hep.21932.
PubMed 17894303
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects
- ClinicalTrials.gov ID
- NCT00299936
- Acronym / sponsor ID
- P02314
- Conditions
- Chronic Hepatitis C
- Keywords
- hepatitis C, chronic hepatitis C, ribavirin, WIN-R
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Schering-Plough
- First posted
- 7 Mar 2006 (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 compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects
Detailed description
Primary Objective:
This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms:
Treatment Arm A:
PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day
OR
Treatment Arm B:
PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day
Arm A \& Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ribavirin, PEG-Intron | Drug | – |
Primary outcome
Not reported in the source record.
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 7 Mar 2006.
- Derived from this study: PubMed 21836471Hu KQ, Freilich B, Brown RS, Brass C, Jacobson IM. Impact of Hispanic or Asian ethnicity on the treatment outcomes of chronic hepatitis C: results from the WIN-R trial. J Clin Gastroenterol. 2011 Sep;45(8):720-6. doi: 10.1097/MCG.0b013e31820d35e3.
- Derived from this study: PubMed 17894323Jacobson IM, Brown RS Jr, McCone J, Black M, Albert C, Dragutsky MS, Siddiqui FA, Hargrave T, Kwo PY, Lambiase L, Galler GW, Araya V, Freilich B, Harvey J, Griffel LH, Brass CA; WIN-R Study Group. Impact of weight-based ribavirin with peginterferon alfa-2b in African Americans with hepatitis C virus genotype 1. Hepatology. 2007 Oct;46(4):982-90. doi: 10.1002/hep.21670.
- Derived from this study: PubMed 17894303Jacobson IM, Brown RS Jr, Freilich B, Afdhal N, Kwo PY, Santoro J, Becker S, Wakil AE, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Pauly MP, Mukhopadhyay P, Griffel LH, Brass CA; WIN-R Study Group. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. Hepatology. 2007 Oct;46(4):971-81. doi: 10.1002/hep.21932.
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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.
Ira M Jacobson, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribavirin, PEG-Intron in people with Chronic Hepatitis C, run by Weill Medical College of Cornell University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299936, which also lists 3 linked publications.
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 7 Mar 2006.