Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial
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
1 other identifier
interventional
64
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2005
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
November 21, 2014
CompletedNovember 21, 2014
November 1, 2014
3 years
September 13, 2005
August 1, 2011
November 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 weeks after the end of treatment
Secondary Outcomes (3)
Number of Participants Discontinuing Early From Study Treatment
through end of study up to 72 weeks
Participants Achieving SVR Categorized by Time of Response
24 weeks after end of treatment
Overall Number of Serious Adverse Events
through end of study up to 72 weeks
Study Arms (2)
Group A consensus interferon+rbv 52 wks
ACTIVE COMPARATORDaily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
Group B CIFN variable duration
EXPERIMENTALCIFN (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)
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- \. 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.
- \. 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.
- \) Compensated liver disease with the following laboratory results at entry:
- 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
- +1 more criteria
You may not qualify if:
- 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.
- \) 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.
- \) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minneapolis Veterans Affairs Medical Centerlead
- Center for Veterans Research and Educationcollaborator
- InterMunecollaborator
- Kadmon Corporation, LLCcollaborator
- US Department of Veterans Affairscollaborator
- San Diego Veterans Healthcare Systemcollaborator
Related Publications (1)
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.
PMID: 21221804RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Samuel B. Ho, MD, Chief GI Section
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel B. Ho, M.D.
US Department of Veterans Affairs
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
July 1, 2005
Primary Completion
July 1, 2008
Study Completion
September 1, 2009
Last Updated
November 21, 2014
Results First Posted
November 21, 2014
Record last verified: 2014-11