Racial Difference in HCV/Host Interactions

NCT00071916 | Completed

• 1 other identifier: 00-091
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 3

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-2b and ribavirin, and identify possible causes for racial differences in response to therapy. The study will enroll a total of 260 participants, age 18 or older, over a 10 period. In the next 5 years 132 subjects will be studied locally, including 112 African Americans and 20 Caucasians. Participants will be recruited from the clinical practices of the hepatologists (liver doctors) at the University of Tennessee Health Science Center and will also be selected from referrals at local hepatology clinics and the Memphis VA Hospital. Volunteers will be treated with pegylated interferon alfa-2b injections once weekly and oral ribavirin 2 times a day for up to 72 weeks. Study procedures include multiple blood draws. Participants may be involved in study related procedures for up to 72 weeks.

Conditions

Hepatitis C

Keywords

Hepatitis C, African Americans, ribavirin

Outcome Measures

Primary Outcomes (3)

• Determine if there is a difference in interferon-induced signaling between patients that respond to therapy and those that do not.

  Analysis.

• Measure and compare the sustained virologic response to standard treatment for hepatitis C between African American (AA) and non AA patients.

  Analysis.

• Determine how human leukocyte antigen (HLA) class II-dependent immune regulation and T cell specificities affect differences in immune responses to hepatitis C (HCV) and response to therapy in African American (AA) patients compared to non AA patients.

  Analysis.

Study Arms (2)

African American

Adult African American participants with compensated chronic hepatitis C who have not been previously been treated with interferon and/or ribavirin.

Caucasian

Caucasian participants with compensated chronic hepatitis C who have not been previously been treated with interferon and/or ribavirin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult, male or female, African-Americans or Caucasians, age 18 or older. Serum positive for hepatitis C.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood. No liver biopsies will be performed specifically for inclusion into the tissue repository. Only slides or paraffin tissue blocks of previously performed liver biopsies will be included in the tissue repository.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 5, 2003
• Study Start: March 1, 2001
• Last Updated: January 31, 2019

Record last verified: 2010-03

Locations

US (3)