Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC
1 other identifier
interventional
610
1 country
1
Brief Summary
The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C. The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2002
Longer than P75 for phase_4
1 active site
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
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFebruary 14, 2012
February 1, 2012
7.9 years
September 14, 2005
February 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.
Serum HCV-RNA will be evaluated at Weeks 0, 12, 24, and 48 during treatment and at Week 24 following the end of therapy. The primary efficacy endpoint is the loss of HCV-RNA at 6 months of follow up.
72 weeks
Secondary Outcomes (1)
The loss of HCV-RNA at 6 months of follow up. If the HCV-RNA has not decreased by one log at treatment week 24, the patient will be classified as a treatment nonresponder and medications are discontinued.
72 weeks
Study Arms (2)
Initial induction therapy
EXPERIMENTALReceive Peg Intron 3.0mcg/kg/wk for 12 weeks followed by Peg Intron 1.5 mcg/kg/wk for 36 weeks
Standard of Care
ACTIVE COMPARATORPeg Inter 1.5mcg/kg/wk for 48 weeks
Interventions
Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks
Eligibility Criteria
You may qualify if:
- willing to give written informed consent and be able to adhere to dose and visit schedules.
- years of age or older of either gender and any race. Subjects who are over 65 years of age must be in generally good health.
- Serum positive for HCV-RNA by PCR assay Treatment naïve Genotype 1 \& 4 HCV participants
- ALT either elevated or persistently normal
- Liver biopsy within 36 months with a pathology report confirming the histological diagnosis is consistent with CHC
- Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit
- Hemoglobin values of \<12 gm/dL for females \& \<13 gm/dL for males.
- WBC \<3,000/mm3
- Neutrophil count \< 1,500/mm3
- Platelets \<65,000/mm3
- Direct bilirubin, within 20% of (ULN)
- Indirect bilirubin, WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise
- Albumin, WNL
- Serum creatinine, within 20% of ULN
- Glucose should be less than 115 mg/dL
- +6 more criteria
You may not qualify if:
- Women who are pregnant or nursing.
- Hepatitis C of non-genotype 1 or 4
- Previous anti-viral therapy
- Suspected hypersensitivity to interferon, PEG-interferon, ribavirin
- Any other cause for the liver disease other than chronic hepatitis C including but not limited to:
- Co-infection with HBV
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Obesity-induced liver disease
- Drug-related liver disease
- Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy
- Hemoglobinopathies
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brooke Army Medical Centerlead
- T.R.U.E. Research Foundationcollaborator
Study Sites (1)
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Related Publications (1)
Brady DE, Torres DM, An JW, Ward JA, Lawitz E, Harrison SA. Induction pegylated interferon alfa-2b in combination with ribavirin in patients with genotypes 1 and 4 chronic hepatitis C: a prospective, randomized, multicenter, open-label study. Clin Gastroenterol Hepatol. 2010 Jan;8(1):66-71.e1. doi: 10.1016/j.cgh.2009.08.036. Epub 2009 Sep 10.
PMID: 19747986BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Harrison, MD
Brooke Army Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 21, 2005
Study Start
February 1, 2002
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 14, 2012
Record last verified: 2012-02