Status:
COMPLETED
Racial Difference in HCV/Host Interactions
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate a group of African Americans and Caucasians with hepatitis C virus (HCV), compare their response rates to combination treatment with pegylated interferon alfa-...
Detailed Description
The University of Tennessee Health Science Center (UTHSC) Memphis Hepatitis C Cooperative Research Center was established in 2000 to support clinical and basic research in understanding the basis for ...
Eligibility Criteria
Inclusion
- Adult, male or female, African-American or Caucasian, age 18 or older.
- Serum positive for hepatitis C virus by Polymerase Chain Reaction (PCR) or other assays \[e.g. Deoxyribonucleic acid, (BDNA)\].
- Liver biopsy prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis.
- Compensated liver disease with the following laboratory parameters at the Entry visit:
- Hemoglobin values of greater than or equal to 12 mg/dL
- Neutrophil count greater than or equal to 1,200/mm\^3
- Platelets greater than or equal to 60,000/mm
- Albumin \> 3.0 g/dL or within 20 percent of lower limit of normal (LLN)
- Serum creatinine less than or equal to 1.5 mg/dL
- Thyroid stimulating hormone (TSH) within normal limits or thyroid disease under control
- Reconfirmation and documentation that sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods (Norplant), medroxyprogesterone acetate (Depo-Provera), surgical sterilization, barrier method (diaphragm + spermicide), or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast-feeding. Documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.
- Written informed consent specific for this protocol has been obtained prior to entry.
Exclusion
- Hypersensitivity to interferon or ribavirin.
- Any cause for chronic liver disease other than chronic hepatitis C.
- Active hemolytic anemia.
- Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
- Any known preexisting medical condition that could interfere with the patient's participation in the protocol including: (Central Nervous System) CNS trauma or uncontrolled seizure disorders; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout' or any medical condition requiring, or likely to require during the course of the study, chronic administration of steroids.
- Patients with evidence of ischemia or stress testing, Electrocardiogram (ECG) evidence of ischemia, a significant arrhythmia, cardiac failure, recent coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months. Pretreatment stress test will be required for all participants greater than 50 years of age or 45 years of age if diabetic.
- Patients with clinically significant retinal abnormalities.
- Substance abuse, such as alcohol (greater than 80 gm/day), intravenous (IV) drugs and inhaled drugs. If the patient has a history of substance abuse, to be considered for inclusion into the protocol, the patient must have abstained from using the abused substance for at least 3 months.
- Patients with a history of organ transplantation will be excluded.
- Patients infected with human immunodeficiency virus.
- Preexisting psychiatric conditions; especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, active suicidal ideation and/or suicidal attempt are excluded. Patients with a history of mild depression may enter the protocol if they meet the following eligibility criterion and are monitored more intensively. Mild depression includes either situational depression for a limited period or depressive symptoms, which do not significantly interfere with the patient's work or daily functions. All patients will complete the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report scale designed to measure depressive symptomatology experienced during the week prior to the interview. The items are scored on a four-point scale (0-3), with the total score ranging from zero to 60. CES-D scores of 16-20 suggest minor depression, and scores greater than 20 suggest major depression. The score can be determined in real time. A score of 16 or higher should prompt further questioning and consideration of treatment or referral to psychiatry. Detailed follow-up of each patient may be individualized according to his/her need; this would usually include predetermined visits.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00071916
Start Date
March 1 2001
Last Update
January 31 2019
Active Locations (3)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72205
2
University of Tennessee
Memphis, Tennessee, United States, 38163
3
Vanderbilt University
Nashville, Tennessee, United States, 37232