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Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ribavirin, Peg interferon alfa 2b
induction therapy
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: willing to give written informed consent and be able to adhere to dose and visit schedules. 18years 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 Thyroid Stimulating Hormone (TSH), WNL HIV negative HBsAg negative Alpha fetoprotein value < 100 ng/mL obtained within one year prior to entry for patients with Stage 3 or 4 liver disease Reconfirmation & documentation sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period & 6 months following the last dose of study medication Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period & for 6 months following the last dose of study medication Exclusion Criteria: 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 Evidence of advanced liver disease (ascites, bleeding varices,spontaneous encephalopathy) organ transplants other than cornea and hair transplant. Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded CNS trauma or active seizure disorders requiring medication Significant cardiovascular dysfunction within the past 12 months. Subjects with ECG showing clinically significant abnormalities Poorly controlled DM Chronic pulmonary disease (COPD)with documented pulmonary hypertension Immunologically mediated disease (e.g., inflammatory bowel disease, RA, idiopathic thrombocytopenia purpura, lupus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids Active gout Substance abuse not willing to be abstain from the consumption of alcohol. clinically significant retinal abnormalities Any other condition that in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol Known HIV Positive

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial induction therapy

Standard of Care

Arm Description

Receive Peg Intron 3.0mcg/kg/wk for 12 weeks followed by Peg Intron 1.5 mcg/kg/wk for 36 weeks

Peg Inter 1.5mcg/kg/wk for 48 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 14, 2005
Last Updated
February 13, 2012
Sponsor
Brooke Army Medical Center
Collaborators
T.R.U.E. Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00207363
Brief Title
Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC
Official Title
Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center
Collaborators
T.R.U.E. Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this study is to determine if the use of induction dose PEG-Intron in combination with Rebetol will enhance the elimination of Hepatitis C in treatment naïve patients with genotype 1 and 4. Currently PEG-Interferon alfa-2b plus Ribavirin results in a sustained response in 54-61% of patients with Hepatitis C. Those with genotype 1and 4 and high viral loads are the most likely to have a less favorable response. The administration of induction dose interferon in combination with Ribavirin may yield an improved sustained response rate in these more difficult to treat patients with chronic Hepatitis C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
610 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial induction therapy
Arm Type
Experimental
Arm Description
Receive Peg Intron 3.0mcg/kg/wk for 12 weeks followed by Peg Intron 1.5 mcg/kg/wk for 36 weeks
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Peg Inter 1.5mcg/kg/wk for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin, Peg interferon alfa 2b
Other Intervention Name(s)
Peg interferon alfa 2b (Peg Intron)
Intervention Description
Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
induction therapy
Other Intervention Name(s)
Peg Intron (peginterferon alfa 2b
Intervention Description
Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: willing to give written informed consent and be able to adhere to dose and visit schedules. 18years 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 Thyroid Stimulating Hormone (TSH), WNL HIV negative HBsAg negative Alpha fetoprotein value < 100 ng/mL obtained within one year prior to entry for patients with Stage 3 or 4 liver disease Reconfirmation & documentation sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period & 6 months following the last dose of study medication Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period & for 6 months following the last dose of study medication Exclusion Criteria: 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 Evidence of advanced liver disease (ascites, bleeding varices,spontaneous encephalopathy) organ transplants other than cornea and hair transplant. Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded CNS trauma or active seizure disorders requiring medication Significant cardiovascular dysfunction within the past 12 months. Subjects with ECG showing clinically significant abnormalities Poorly controlled DM Chronic pulmonary disease (COPD)with documented pulmonary hypertension Immunologically mediated disease (e.g., inflammatory bowel disease, RA, idiopathic thrombocytopenia purpura, lupus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids Active gout Substance abuse not willing to be abstain from the consumption of alcohol. clinically significant retinal abnormalities Any other condition that in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol Known HIV Positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Harrison, MD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Ft. Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19747986
Citation
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.
Results Reference
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Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC

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