Interferon-Induced Gene Expression in Liver Cells and Peripheral Blood Lymphocytes

NCT00324389 | Completed Phase 2

• 1 other identifier: 04-014
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal seeks to use DNA analyses to understand how racial and genetic factors influence interferon (treatment) response in HCV infection in African Americans. A better understanding should allow rational design of new therapies or better use of existing therapies. Patients will provide medical history and undergo a physical exam, blood draws, electrocardiogram, possible chest x-ray, and abdominal ultrasound. Patients will be admitted to the hospital for 5 days and undergo 2 liver biopsies, sedation, and multiple blood draws. Twenty adult male volunteers (10 Caucasians,10 African Americans) ages 18 - 65 years will participate.

Conditions

Hepatitis C

Keywords

Interferon, Gene Expression in Liver, Lymphocytes, High Density Oligonucleotide Microarray Expression Analysis, African American, Hepatitis C

Interventions

Interferon alpha DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male non-Hispanic African-American or non-Hispanic Caucasian patients between 18 and 65 years of age
• Abstinence from any ingestion of alcohol and smoking for at least 7 days prior to study for those who drink or smoke socially
• HCV genotype 1 (1a, 1b or mixture of 1a and 1b). HCV genotyping will be performed at the Molecular Diagnostic Laboratory at UTMB using the LiPA assay (Innogenetics)
• Presence of HCV RNA in serum (\>10 \[to the fifth power\] copies/ml)
• Not previously treated with any interferon and/ or ribavirin
• Compensated liver disease with the following laboratory criteria:
• Hemoglobin greater than or equal to 13 gm/dl for males
• Granulocyte count greater than or equal to 1,000/cubic mm
• Platelets greater than or equal to 100,000/cubic mm
• Prothrombin time \<2 sec. elevation
• Total bilirubin (0.1-1.1 mg/dl). If elevated, the conjugated Bilirubin must be within normal limits (0-0.3 mg/dl)
• Serum albumin within normal limits (3.5-5.0 g/dl)
• Serum creatinine within normal limits (0.7-1.7 mg/ml)
• Absence of other known causes of liver disease (e.g. autoimmune hepatitis, hemochromatosis, Wilson's diseases, alpha-1 anti-trypsin deficiency, drug-induced liver injury, alcoholic liver disease)
• No other systemic antiviral or immunosuppressive therapy within the last 6 months

You may not qualify if:

• Interferon or ribavirin therapy at any previous time
• Any investigational drug \<= 24 weeks prior to the first dose of study drug
• Any alternative or folk medicine within 24 weeks of screening
• Any systemic antiviral therapy \<= 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. Exception: patients who have taken or are expected to require acyclovir for herpetic lesions
• Patient with a baseline increased risk for anemia (e.g. hemoglobinopathies such as thalassemia, spherocytosis, sickle cell anemia or a history of symptomatic recurring GI bleeding, etc.) or for whom anemia would be medically problematic
• Evidence of alcohol and/or drug abuse within 6 months
• History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical evidence of rheumatoid arthritis)
• Evidence of an active or suspected cancer or a history of malignancy
• History of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \<= 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
• History of major organ transplantation with an existing functional graft
• History of bone marrow transplantation
• Anything that in the opinion of the investigator puts the patient at increased risk, or increases the likelihood that the patient may not be able to complete the protocol

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Interferon-alpha

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

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: May 1, 2006
• Study Completion: June 1, 2006
• Last Updated: August 27, 2010

Record last verified: 2009-04

Locations

US (1)