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

February 13, 2012 updated by: Stephen A Harrison, Brooke Army Medical Center

Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

610

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Ft. Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial induction therapy
Receive Peg Intron 3.0mcg/kg/wk for 12 weeks followed by Peg Intron 1.5 mcg/kg/wk for 36 weeks
Drug: induction therapy
Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks
Other Names:
  • Peg Intron (peginterferon alfa 2b
Active Comparator: Standard of Care
Peg Inter 1.5mcg/kg/wk for 48 weeks
Drug: Ribavirin, Peg interferon alfa 2b
Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
Other Names:
  • Peg interferon alfa 2b (Peg Intron)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 72 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 72 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

T.R.U.E. Research Foundation

Investigators

  • Principal Investigator: Stephen Harrison, MD, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2002.076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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