Hepatitis CPhase 4ENHANCENCT00456248
Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin
A Phase 4 study testing Infergen and ribavirin in people with Hepatitis C, run by Kadmon Corporation, LLC at 4 sites in United States.
Trial summary
This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Infergen and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2007to Oct 2007
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
- Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
- The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
- Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
- Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin
Who cannot join
- Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in HCV RNA at Week 12 from baseline.
- HCV Genotype 2 or 3
- Severe neuropsychiatric disorder.
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
- Known HIV infection or positive HIV at screening.
- Pregnant or breast-feeding patients.
- Underlying autoimmune disease
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Atlantic Gastroenterology Associates
Atlanta, Georgia
Liver Institute at Methodist Dallas
Dallas, Texas
Caroline Digestive Health Associates
Harrisburg, North Carolina
Tulane University School of Medicine
New Orleans, Louisiana
About this study
Official title: Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy
This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.
- Conditions
- Hepatitis C
- Being tested
- Infergen and ribavirin
- Keywords
- Chronic Hepatitis C, Liver, Pegylated, Interferon, Ribavirin, Combination, Nonresponder, Relapser, HCV, Infergen, SVR
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infergen and ribavirinDrug
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Infergen 15 ug QD plus RBV for 36 weeks Receives: Drug: Infergen and ribavirin |
| 2 | Experimental | Infergen 15 ug QD plus RBV for 48 weeks Receives: Drug: Infergen and ribavirin |
| 3 | Active comparator | Not described Receives: Drug: Infergen and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period.
Measured: 1.5 years
Secondary outcomes (1)
Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell L Schiffman, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456248
- Sponsor's protocol ID
- VRX-CIFN-402
- Acronym
- ENHANCE
- Status last verified
- Oct 2012
- First submitted
- 2 Apr 2007
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT00456248
- Acronym / sponsor ID
- ENHANCE / VRX-CIFN-402
- Conditions
- Hepatitis C
- Keywords
- Chronic Hepatitis C, Liver, Pegylated, Interferon, Ribavirin, Combination, Nonresponder, Relapser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 Apr 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.
This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Infergen and ribavirinInfergen 15 ug QD plus RBV for 36 weeks |
| 2 | Experimental | Drug: Infergen and ribavirinInfergen 15 ug QD plus RBV for 48 weeks |
| 3 | Active comparator | Drug: Infergen and ribavirin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
- Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
- The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
- Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
- Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin
Key exclusion criteria (7 listed)
- Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in HCV RNA at Week 12 from baseline.
- HCV Genotype 2 or 3
- Severe neuropsychiatric disorder.
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
- Known HIV infection or positive HIV at screening.
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 |
|---|---|---|
| Infergen and ribavirinInfergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks | Drug | 1, 2, 3 |
Primary outcome
To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period.
Time frame: 1.5 years
1 secondary outcome
Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks
Time frame: 1.5 years
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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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.
Mitchell L Schiffman, MD principal investigator
Virginia Commonwealth University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infergen and ribavirin in people with Hepatitis C, run by Kadmon Corporation, LLC at 4 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: slow enrollment). Results are not available in the source record.
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?
To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period. (time frame: 1.5 years). 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 15 Oct 2012.