Chronic Hepatitis CPhase 3NCT00211692
Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial
A Phase 3 study testing consensus interferon (Interferon Alfacon-1) and ribavirin and Consensus Interferon alfa (CIFN) and ribavirin in people with Chronic Hepatitis C, run by Minneapolis Veterans Affairs Medical Center.
Trial summary
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- consensus interferon (Interferon Alfacon-1) and ribavirin and Consensus Interferon alfa (CIFN) and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Sep 2009
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Chronic hepatitis C. This is defined as the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C PCR test and a positive HCV genotype test for genotype 1, and a liver biopsy (within the previous 5 years) that is compatible with chronic hepatitis. In the case of patients that have refused liver biopsies a clinical diagnosis of chronic hepatitis C is required.
- 2. Positive HCV RNA by PCR, Genotype 1, treatment naive 3. Age 18-65 years. 4. Patient must be able to give informed consent. 5. Eligible for interferon alfa and ribavirin-based antiviral treatment:
- Reconfirmation and documentation that sexually active female patients of childbearing potential are practicing adequate contraception. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative.
- Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period and for six months following the last dose of study medication.
- For patients with cirrhosis or stage 4 fibrosis on liver biopsy, they must have an alpha fetoprotein (AFP) value < 80 ng/mL obtained within 3 months prior to entry. Cirrhotics with an alpha fetoprotein value >30 ng/mL but <80ng/mL may be enrolled after a normal ultrasound or triphasic CT scan within the previous 3 months. Cirrhotics with alpha fetoprotein levels up to 30 ng/ml must have an ultrasound or CT scan within 6 months of enrolling that is negative for hepatocellular cancer. Patients with an AFP > 80 ng/mL may not be enrolled.
- 5) Compensated liver disease with the following laboratory results at entry:
Show all 16Show fewer
- Hemoglobin >=to 12 gm/dL for females and >= 13gm/dl for males
- WBC >= 2,000/mm3
- Neutrophil >=1,500/mm3
- Platelets >=75,000/mm3
- Albumin > 3.0 g/dL
- Total bilirubin <2.0
- Serum creatinine < 1.4 mg/dL
- INR <1.8
- If diabetic, must have glycosylated Hgb test that demonstrates adequate control of diabetes in the opinion of the investigator
- TSH within normal limits
Who cannot join
- Patient unable or unwilling to participate.
- Liver disease in addition to chronic hepatitis C (HBsAg positive, autoimmune liver disease, hemochromatosis, PBC, PSC, alpha-1 antitrypsin deficiency, Wilson's disease, etc.)
- Decompensated liver disease, with history of encephalopathy, variceal bleeding, or ascites or CHILD-PUGH class B or C.
- Baseline BDI > 19 or current suicidal or homicidal ideation. (Note: if baseline BDI is > 19 pt. will require a psychiatric evaluation and treatment; if deemed stable after this he may be considered according to site PI clinical judgment.)
- Current substance use disorder (Must be evaluated and demonstrate engagement and compliance with care before they will be eligible).
- Patients with active or uncontrolled psychiatric disease including patients who have had recent prior severe psychiatric disease (hospitalized) within the last 2 years.
Show all 10Show fewer
- Accepted and reasonable exclusion criteria for interferon alfa and ribavirin based treatments:
- 1) CNS trauma or active seizure disorders requiring medication. 2) Significant cardiovascular dysfunction within the past 12 months 3) Poorly controlled diabetes mellitus (in the opinion of the site PI). 4) Moderate or severe chronic pulmonary disease 5) Clinically significant immunologically mediated disease 6) Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
- 7) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- 8) Hypersensitivity to interferon alfa or ribavirin 9) Known anti-HIV positive 10) Clinically significant retinopathy 11) Previous solid organ transplantation 12) Any condition that, in the opinion of the investigator, will prevent the patient from being compliant with study medications or appointments.
About this study
Official title: Prospective Randomized Pilot Study of Daily Consensus Interferon (CIFN) and Ribavirin for 52 Wks vs Extended Duration 72 Wks Based on Virologic Response for the Initial Treatment of Difficult-to-treat Patients With Chronic HCV Genotype 1
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These data indicate that the use of a regimen of daily CIFN and ribavirin will lead to greater virologic response rates compared with pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed virologic response to initial therapy may benefit from an extended duration of therapy. Therefore, the goals of this pilot study are to determine the tolerability and efficacy of daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The target population will consist of "difficult-to-treat" patients, defined as having the following characteristics: genotype 1, a North American patient population, predominantly male gender, and no specific exclusions for pre-existing psychiatric or substance abuse co-morbidities.
Read the detailed description
Current treatment for hepatitis C is a pegylated interferon alfa plus ribavirin. This treatment is inadequate for patients with HCV genotype 1, since the majority of patients do not respond (termed non-responders) or respond but relapse (termed relapsers) following termination of these treatments. Data from the Veterans Health Administration (VHA) Hepatitis C Registry and community hospitals indicate that the large majority of patients identified with hepatitis C have characteristics associated with a poor treatment response and remain untreated at this time. Data have suggested that consensus interferon (CIFN, CIFN or interferon alfacon-1) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Preliminary data indicate that more patients with genotype 1 can respond to CIFN and ribavirin than current standard treatments, due to the fact that approximately 25% of patients who are nonresponders to pegylated interferon and ribavirin may have a sustained response to a regimen of daily CIFN and ribavirin. Furthermore, difficult to treat patients may benefit from a longer duration of therapy than the standard 48 week regimen based on when an initial virologic response to therapy occurs.
Aims: To determine the safety and efficacy of (A) daily CIFN (15 mcg/d sq) and ribavirin (1-1.2 gm/d PO) given for 52 weeks, vs (B) daily CIFN (15 mcg/d sq) and ribavirin (1-1.2 gm/d PO) given for 52 to 72 weeks for treatment-naïve patients with hepatitis C genotype 1, with treatment duration based on the virologic response during the initial 24 weeks.
Methods: Patients who meet eligibility criteria will be stratified by race and randomized to one of two treatment arms, and all patients will have viral kinetics measured by quantitative PCR at weeks 4,8,12,16,20 and 24. Patients in treatment arm A will follow "standard" stopping rules, i.e., if there is not a 2-log drop in viremia by 12 weeks the treatment will be discontinued, otherwise they will all receive 52 weeks of treatment if they also are qualitative PCR negative by week 24. In treatment arm B the patients will be monitored monthly until they have a virologic response (defined as >2 log drop in viral levels from baseline) by quantitative PCR for up to 24 weeks. Once they have a virologic response by quantitative PCR their treatment will be continued for an additional 48 weeks. In both groups, treatment will be stopped if the patients do not become negative for HCV RNA by qualitative PCR by 24 weeks on therapy. A total of 192 patients at up to 10-20 sites will be recruited. The primary endpoint would be the number who achieve a sustained virologic response; secondary endpoints are the percentage of patients who complete therapy, have significant adverse events, and the relationship of early virologic response at each 4 week period between 4 and 24 weeks and those who achieve a sustained virologic response.
Sample size determination: To detect an absolute difference of 20% or more in sustained virologic response between treatment arms A and B; the Log-rank test is performed at the alpha level of .05 and the test is maintained at least 80 percent statistical power; it is estimated that a total of 96 patients in each treatment arm will be required.
Analysis: Univariate and multivariate analysis will be used to determine factors associated with final endpoints. Subgroup analyses will be done based on time to early virologic response and duration of therapy each stratification. The primary and secondary endpoints will be determined on an intention-to-treat basis starting with all patients that receive at least one dose of study medications. The primary and secondary endpoints will also be determined in a per-protocol analysis on those patients who take 80% of the prescribed CIFN and 80% of the prescribed ribavirin for 80% of the time.
Significance: The current initial treatment of pegylated interferon alfa and ribavirin for patients with hepatitis C who are genotype 1 and have other "difficult-to-treat" characteristics is inadequate. The results of this trial are needed to demonstrate the safety and efficacy of two regimens of daily CIFN and ribavirin. Since the large majority of hepatitis C patients in VA and other community hospitals fall into this category, the results of this trial may influence the potential treatments recommended for these patients.
- Conditions
- Chronic Hepatitis C
- Being tested
- consensus interferon (Interferon Alfacon-1) and ribavirin, Consensus Interferon alfa (CIFN) and ribavirin
- Keywords
- Hepatitis C, interferon alfa, ribavirin, interferon alfacon-1, antiviral therapy
- 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.
consensus interferon (Interferon Alfacon-1) and ribavirinDrug
Also called interferon alfacon-1
CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
Consensus Interferon alfa (CIFN) and ribavirinDrug
Also called interferon alfacon-1
CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
| Study group | Role | What they receive |
|---|---|---|
| Group A consensus interferon+rbv 52 wks | Active comparator | Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A) Receives: Drug: consensus interferon (Interferon Alfacon-1) and ribavirin; Drug: Consensus Interferon alfa (CIFN) and ribavirin |
| Group B CIFN variable duration | Experimental | CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B) Receives: Drug: Consensus Interferon alfa (CIFN) and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.
Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study
Measured: 24 weeks after the end of treatment
Secondary outcomes (3)
Number of Participants Discontinuing Early From Study Treatment
Measured: through end of study up to 72 weeks
Participants Achieving SVR Categorized by Time of Response
rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks
Measured: 24 weeks after end of treatment
Overall Number of Serious Adverse Events
Measured: through end of study up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2008
- Study completionSep 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Center for Veterans Research and Education, InterMune, Kadmon Corporation, LLC, US Department of Veterans Affairs, San Diego Veterans Healthcare System
- Responsible party
- Principal investigator, Samuel B. Ho, Minneapolis Veterans Affairs Medical Center
- Investigators
- Samuel B. Ho, M.D., Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211692
- Sponsor's protocol ID
- MVRI001
- Status last verified
- Nov 2014
- First submitted
- 13 Sep 2005
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ho SB, Aqel B, Dieperink E, Liu S, Tetrick L, Falck-Ytter Y, DeComarmond C, Smith CI, McKee DP, Boyd W, Kulig CC, Bini EJ, Pedrosa MC. U.S. multicenter pilot study of daily consensus interferon (CIFN) plus ribavirin for "difficult-to-treat" HCV genotype 1 patients. Dig Dis Sci. 2011 Mar;56(3):880-8. doi: 10.1007/s10620-010-1504-y. Epub 2011 Jan 11.
PubMed 21221804
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Pilot Study of Daily Consensus Interferon (CIFN) and Ribavirin for 52 Wks vs Extended Duration 72 Wks Based on Virologic Response for the Initial Treatment of Difficult-to-treat Patients With Chronic HCV Genotype 1
- ClinicalTrials.gov ID
- NCT00211692
- Acronym / sponsor ID
- MVRI001
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, interferon alfa, ribavirin, interferon alfacon-1, antiviral therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Center for Veterans Research and Education, InterMune, Kadmon Corporation, LLC, US Department of Veterans Affairs, San Diego Veterans Healthcare System
- Study start
- Jul 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These data indicate that the use of a regimen of daily CIFN and ribavirin will lead to greater virologic response rates compared with pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed virologic response to initial therapy may benefit from an extended duration of therapy. Therefore, the goals of this pilot study are to determine the tolerability and efficacy of daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The target population will consist of "difficult-to-treat" patients, defined as having the following characteristics: genotype 1, a North American patient population, predominantly male gender, and no specific exclusions for pre-existing psychiatric or substance abuse co-morbidities.
Detailed description
Current treatment for hepatitis C is a pegylated interferon alfa plus ribavirin. This treatment is inadequate for patients with HCV genotype 1, since the majority of patients do not respond (termed non-responders) or respond but relapse (termed relapsers) following termination of these treatments. Data from the Veterans Health Administration (VHA) Hepatitis C Registry and community hospitals indicate that the large majority of patients identified with hepatitis C have characteristics associated with a poor treatment response and remain untreated at this time. Data have suggested that consensus interferon (CIFN, CIFN or interferon alfacon-1) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Preliminary data indicate that more patients with genotype 1 can respond to CIFN and ribavirin than current standard treatments, due to the fact that approximately 25% of patients who are nonresponders to pegylated interferon and ribavirin may have a sustained response to a regimen of daily CIFN and ribavirin. Furthermore, difficult to treat patients may benefit from a longer duration of therapy than the standard 48 week regimen based on when an initial virologic response to therapy occurs.
Aims: To determine the safety and efficacy of (A) daily CIFN (15 mcg/d sq) and ribavirin (1-1.2 gm/d PO) given for 52 weeks, vs (B) daily CIFN (15 mcg/d sq) and ribavirin (1-1.2 gm/d PO) given for 52 to 72 weeks for treatment-naïve patients with hepatitis C genotype 1, with treatment duration based on the virologic response during the initial 24 weeks.
Methods: Patients who meet eligibility criteria will be stratified by race and randomized to one of two treatment arms, and all patients will have viral kinetics measured by quantitative PCR at weeks 4,8,12,16,20 and 24. Patients in treatment arm A will follow "standard" stopping rules, i.e., if there is not a 2-log drop in viremia by 12 weeks the treatment will be discontinued, otherwise they will all receive 52 weeks of treatment if they also are qualitative PCR negative by week 24. In treatment arm B the patients will be monitored monthly until they have a virologic response (defined as >2 log drop in viral levels from baseline) by quantitative PCR for up to 24 weeks. Once they have a virologic response by quantitative PCR their treatment will be continued for an additional 48 weeks. In both groups, treatment will be stopped if the patients do not become negative for HCV RNA by qualitative PCR by 24 weeks on therapy. A total of 192 patients at up to 10-20 sites will be recruited. The primary endpoint would be the number who achieve a sustained virologic response; secondary endpoints are the percentage of patients who complete therapy, have significant adverse events, and the relationship of early virologic response at each 4 week period between 4 and 24 weeks and those who achieve a sustained virologic response.
Sample size determination: To detect an absolute difference of 20% or more in sustained virologic response between treatment arms A and B; the Log-rank test is performed at the alpha level of .05 and the test is maintained at least 80 percent statistical power; it is estimated that a total of 96 patients in each treatment arm will be required.
Analysis: Univariate and multivariate analysis will be used to determine factors associated with final endpoints. Subgroup analyses will be done based on time to early virologic response and duration of therapy each stratification. The primary and secondary endpoints will be determined on an intention-to-treat basis starting with all patients that receive at least one dose of study medications. The primary and secondary endpoints will also be determined in a per-protocol analysis on those patients who take 80% of the prescribed CIFN and 80% of the prescribed ribavirin for 80% of the time.
Significance: The current initial treatment of pegylated interferon alfa and ribavirin for patients with hepatitis C who are genotype 1 and have other "difficult-to-treat" characteristics is inadequate. The results of this trial are needed to demonstrate the safety and efficacy of two regimens of daily CIFN and ribavirin. Since the large majority of hepatitis C patients in VA and other community hospitals fall into this category, the results of this trial may influence the potential treatments recommended for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A consensus interferon+rbv 52 wks | Active comparator | Drug: consensus interferon (Interferon Alfacon-1) and ribavirin, Drug: Consensus Interferon alfa (CIFN) and ribavirinDaily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A) |
| Group B CIFN variable duration | Experimental | Drug: Consensus Interferon alfa (CIFN) and ribavirinCIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Chronic hepatitis C. This is defined as the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C PCR test and a positive HCV genotype test for genotype 1, and a liver biopsy (within the previous 5 years) that is compatible with chronic hepatitis. In the case of patients that have refused liver biopsies a clinical diagnosis of chronic hepatitis C is required.
- 2. Positive HCV RNA by PCR, Genotype 1, treatment naive 3. Age 18-65 years. 4. Patient must be able to give informed consent. 5. Eligible for interferon alfa and ribavirin-based antiviral treatment:
- Reconfirmation and documentation that sexually active female patients of childbearing potential are practicing adequate contraception. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative.
- Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period and for six months following the last dose of study medication.
- For patients with cirrhosis or stage 4 fibrosis on liver biopsy, they must have an alpha fetoprotein (AFP) value < 80 ng/mL obtained within 3 months prior to entry. Cirrhotics with an alpha fetoprotein value >30 ng/mL but <80ng/mL may be enrolled after a normal ultrasound or triphasic CT scan within the previous 3 months. Cirrhotics with alpha fetoprotein levels up to 30 ng/ml must have an ultrasound or CT scan within 6 months of enrolling that is negative for hepatocellular cancer. Patients with an AFP > 80 ng/mL may not be enrolled.
Key exclusion criteria (10 listed)
- Patient unable or unwilling to participate.
- Liver disease in addition to chronic hepatitis C (HBsAg positive, autoimmune liver disease, hemochromatosis, PBC, PSC, alpha-1 antitrypsin deficiency, Wilson's disease, etc.)
- Decompensated liver disease, with history of encephalopathy, variceal bleeding, or ascites or CHILD-PUGH class B or C.
- Baseline BDI > 19 or current suicidal or homicidal ideation. (Note: if baseline BDI is > 19 pt. will require a psychiatric evaluation and treatment; if deemed stable after this he may be considered according to site PI clinical judgment.)
- Current substance use disorder (Must be evaluated and demonstrate engagement and compliance with care before they will be eligible).
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 |
|---|---|---|
| consensus interferon (Interferon Alfacon-1) and ribavirinAlso: interferon alfacon-1CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B) | Drug | Group A consensus interferon+rbv 52 wks |
| Consensus Interferon alfa (CIFN) and ribavirinAlso: interferon alfacon-1CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B) | Drug | Group A consensus interferon+rbv 52 wks, Group B CIFN variable duration |
Primary outcome
The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.
Time frame: 24 weeks after the end of treatment
Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study
3 secondary outcomes
Number of Participants Discontinuing Early From Study Treatment
Time frame: through end of study up to 72 weeks
Participants Achieving SVR Categorized by Time of Response
Time frame: 24 weeks after end of treatment
Overall Number of Serious Adverse Events
Time frame: through end of study up to 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21221804Ho SB, Aqel B, Dieperink E, Liu S, Tetrick L, Falck-Ytter Y, DeComarmond C, Smith CI, McKee DP, Boyd W, Kulig CC, Bini EJ, Pedrosa MC. U.S. multicenter pilot study of daily consensus interferon (CIFN) plus ribavirin for "difficult-to-treat" HCV genotype 1 patients. Dig Dis Sci. 2011 Mar;56(3):880-8. doi: 10.1007/s10620-010-1504-y. Epub 2011 Jan 11.
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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.
Samuel B. Ho, M.D. principal investigator
US Department of Veterans Affairs
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing consensus interferon (Interferon Alfacon-1) and ribavirin and Consensus Interferon alfa (CIFN) and ribavirin in people with Chronic Hepatitis C, run by Minneapolis Veterans Affairs Medical Center.
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 16 inclusion and 10 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 21 Nov 2014. 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?
Yes. Results are posted in the registry (first posted 21 Nov 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?
The Primary Endpoint Would be the Number Who Achieve a 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?
On the ClinicalTrials.gov record for NCT00211692, which also lists 1 linked publication.
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 21 Nov 2014.