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

This study has been completed.
Sponsor:
Collaborator:
T.R.U.E. Research Foundation
Information provided by (Responsible Party):
Stephen A Harrison, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00207363
First received: September 14, 2005
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Ribavirin, Peg interferon alfa 2b
Drug: induction therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

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. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 610
Study Start Date: February 2002
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Peg interferon alfa 2b (Peg Intron)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207363

Locations
United States, Texas
Brooke Army Medical Center
Ft. Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
T.R.U.E. Research Foundation
Investigators
Principal Investigator: Stephen Harrison, MD Brooke Army Medical Center
  More Information

Publications:
Responsible Party: Stephen A Harrison, Principal Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00207363     History of Changes
Other Study ID Numbers: C2002.076
Study First Received: September 14, 2005
Last Updated: February 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014