Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9

November 23, 2009 updated by: Pacific Health Foundation

Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9: a Phase IV, Randomized, Open-labeled, Multicenter Trial Comparing 24-week vs. 48-week Therapy

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24 weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
    • California
      • San Diego, California, United States, 92115
        • San Diego Gastroenterology Clinic
      • San Jose, California, United States, 95116
        • San Jose Gastroenterology
      • Westminster, California, United States, 92843
        • Westminster Gastroenterology Clinic
    • Texas
      • Houston, Texas, United States, 77072
        • Houston Gastroenterology Clinic
      • Plano, Texas, United States, 75093
        • Digestive Health Associates of Texas

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:

The subject must meet the following criteria for entry.

  • Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
  • Adult subjects 18-70 years of age of both gender and any race as long as they have HCV genotype 6, 7, 8, and 9.
  • Serum positive for HCV-RNA by PCR (qPCR) assay, or bDNA
  • Liver biopsy within 24 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis C with stage II or more fibrosis. Biopsy must be scored or be re-read to score fibrosis stage and grade and severity of steatosis.

  • Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit (WNL = within normal limits).

    • Hemoglobin (Hb) greater than or equal to12 gm/dL for women and 13 gm/dL for men.
    • White blood cell count (WBC) greater than or equal to 2,000/mm3
    • Platelets (PLT) greater than or equal to 90,000/mm3
    • Direct bilirubin (DB) less than or equal to 1.0
    • Indirect bilirubin (IB) = WNL or greater than or equal to 3.0 mg/dL if this is due to non-hepatitis related factors such as Gilbert's disease.
    • Creatinine (Cr) clearance greater than or equal to50 mL/minute or serum Cr greater than or equal to 1.5x UNL at screening.
  • Fasting glucose (FBS) less than or equal to160 mg/dL and Hb A1c greater than or equal to 8.5% for diabetic subjects (whether on medication or diet controlled).
  • Thyroid Stimulating Hormone (TSH) = WNL (Subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.)
  • Serum anti-HIV = negative
  • Serum HBsAg = negative
  • Abdominal ultrasound negative for liver masses within 3 months prior to entry. Patients without cirrhosis or transition to cirrhosis may have there imaging studies done within 12 months of study entry.
  • Alpha-fetoprotein (AFP) less than or equal to 20 ng/mL obtained within 3 months prior to entry. Patients with 20 ng/mL less than or equal to AFP less than or equal to 100ng/mL may be enrolled after a normal biphasic abdominal CT within the previous 3 months if patients have Stage III/IV fibrosis and after a normal ultrasound if patients have Stage I/II fibrosis. If AFP is more than 100 but less than 200 ng/dL, all patients need to have a negative biphasic CT within 3 months.
  • Female subjects must not be breast-feeding.
  • A pregnancy test must be obtained within 24 hours to the first dose of study drugs and must be negative.
  • Additionally, all fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months after treatment completion.
  • Acceptable forms of contraception may include intrauterine device, oral contraceptives, progesterone implanted rods [Norplant], medroxyprogesterone acetate [Depo-Provera], surgical sterilization, barrier method [diaphragm + spermicide or condom + spermicide]

Exclusion Criteria:

The subject will be excluded from entry if any of the following criteria apply:

  • Women who are pregnant or breast feeding.
  • Male partners of women who are pregnant.
  • Suspected hypersensitivity to interferon, PEG-interferon or Copegus.
  • Treatment with any investigational drug within 45 days of entry to this protocol.
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment greater than or equal to6 months prior to the first dose of study drug, except PEG-IFN alfa-2b and ribavirin. This includes amantadine, mycophenolate mofetil, thymosine alpha, viramidine, levovirin, supraphysiologic doses of steroids (greater than or equal to 10 mg/d for greater than or equal to 14 consecutive days of prednisone or equivalence) and radiation, exception: patients who have had a limited (greater than or equal to 7 day) course of acyclovir or valacyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.

  • Any other cause for the liver disease other than chronic hepatitis C including but not limited to:

    • Co-infection with HBV
    • Hemochromatosis (iron deposition greater than or equal to2+ or severe in liver parenchyma)
    • Alpha-1 antitrypsin deficiency
    • Wilson's disease
    • Autoimmune hepatitis
    • Alcoholic liver disease
    • Significant obesity-induced liver disease (elevated ALT with BMI greater than or equal to 30)
    • Drug-related liver disease
  • Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy.
  • Hemoglobinopathies (e.g., Thalassemia) with significant anemia.
  • History or other evidence of decompensated liver disease or a Child-Pugh score 6. Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
  • Patients with history of hepatocellular carcinoma.

  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:

    • A history of 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. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the subject is clinically stable. The Investigator will formulate a management plan for each of the subjects that will become a part of the subject's medical record. The management plans may be developed in conjunction with a health care professional trained in psychology. For these subjects, the Investigator will review the subject's mental status at every visit.
    • CNS trauma or active seizure disorders requiring medication.
    • Significant cardiovascular dysfunction within the past 12 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe uncontrolled hypertension or significant arrhythmia). Subjects with ECG showing clinically significant abnormalities.
    • Poorly controlled diabetes mellitus.
    • Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease), documented pulmonary hypertension.
    • Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis).
    • Clinical gout.
    • Any patient with an increased baseline risk for anemia (e.g. thalassemia other than thalassemia trait, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
    • Patients in whom, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated.
    • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
    • History of major organ transplantation with an existing functional graft
  • Substance abuse, such as alcohol (greater than or equal to 80 gm/day), IV drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 12 months. Stable subjects enrolled in a methadone maintenance program for at least one year may be enrolled if they are otherwise eligible and are monitored throughout the study for illicit drug use.
  • Subjects not willing to abstain from the consumption of alcohol.
  • Subjects with severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically significant retinal abnormalities.
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.
  • Any other condition, which in the opinion of the Investigators would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.

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
Other: A
Pegylated interferon and ribavirin for 24 weeks
Drug: Pegylated interferon and ribavirin
180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.
Other Names:
  • Pegasys and Copegus
Other: B
Pegylated interferon and ribavirin for 48 weeks
Drug: Pegylated interferon and ribavirin
180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.
Other Names:
  • Pegasys and Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virologic response
Time Frame: 24 weeks post-treatment
24 weeks post-treatment

Collaborators and Investigators

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

Sponsor

Pacific Health Foundation

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Mindie H Nguyen, M.D., M.A.S., Stanford University Medical Center and Pacific Health Foundation

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

October 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 15, 2007

First Submitted That Met QC Criteria

December 15, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEG-183
  • IRB Protocol #20041038
  • IRB Study #1059635

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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