Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215865
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-20
Brief Title:
PEG-Interferon a-2b Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b Ribavirin Therapy
Sponsor:
Hepatitis Resource Network
Organization:
Hepatitis Resource Network
Study Overview
Official Title:
HRN 003PEG-Interferon a-2b Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b Ribavirin Therapy
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HRN-003 STUDY SYNOPSIS
OBJECTIVE To compare the Sustained Virologic Response SVR of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing
OVERVIEW OF STUDY DESIGN This is a multi-center randomized open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly ribavirin by mouth twice daily for 48 weeks
STUDY POPULATION 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy
DOSAGE AND ADMINISTRATION Eligible participants will be randomized to receive PEGIntron weight-adjusted dose 15 mgkg by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose 150 mg if weight than 80 kg or 100 mg if weight 80 KG by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks
EFFICACY EVALUATIONS Laboratory analysis quality of life assessments and change in study medication doses will be obtained
SAFETY EVALUATIONS Assessment of laboratory evaluations vital signs incidence and severity of adverse experiences and progression of disease as measured by HCV viral load
STUDY DESIGN
This is a treatment protocol to evaluate the antiviral efficacy safety and tolerability polyethylene glycol PEG conjugated interferon alfa-2b PEGIntron for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy Patients will be stratified according to their response to the previous course of therapy ie non-reponse or relapse virologic pattern
This is a multi-center randomized open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period
Eligible participants will be randomized to receive PEGIntron weight-adjusted dose 15 mgkg by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose 150 mg if weight than 80 kg or 100 mg if weight 80 KG by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks
Group A PEGIntron weight -adjusted dose 15 mgkg by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks Total therapy x 48weeks
Group B PEGIntron fixed dose 150 mg if weight than 80 kg or 100 mg if weight 80 KG by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for an additional 48 weeks Total therapy x 48 weeks
OBJECTIVE To compare the Sustained Virologic Response SVR of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing
OVERVIEW OF STUDY DESIGN This is a multi-center randomized open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly ribavirin by mouth twice daily for 48 weeks
STUDY POPULATION 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy
DOSAGE AND ADMINISTRATION Eligible participants will be randomized to receive PEGIntron weight-adjusted dose 15 mgkg by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose 150 mg if weight than 80 kg or 100 mg if weight 80 KG by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks
EFFICACY EVALUATIONS Laboratory analysis quality of life assessments and change in study medication doses will be obtained
SAFETY EVALUATIONS Assessment of laboratory evaluations vital signs incidence and severity of adverse experiences and progression of disease as measured by HCV viral load
STUDY DESIGN
This is a treatment protocol to evaluate the antiviral efficacy safety and tolerability polyethylene glycol PEG conjugated interferon alfa-2b PEGIntron for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy Patients will be stratified according to their response to the previous course of therapy ie non-reponse or relapse virologic pattern
This is a multi-center randomized open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period
Eligible participants will be randomized to receive PEGIntron weight-adjusted dose 15 mgkg by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose 150 mg if weight than 80 kg or 100 mg if weight 80 KG by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks
Group A PEGIntron weight -adjusted dose 15 mgkg by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for 48 weeks Total therapy x 48weeks
Group B PEGIntron fixed dose 150 mg if weight than 80 kg or 100 mg if weight 80 KG by subcutaneous injection weekly ribavirin 400 mg by mouth twice daily for an additional 48 weeks Total therapy x 48 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None