- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324389
Interferon-Induced Gene Expression in Liver Cells and Peripheral Blood Lymphocytes
A Pilot Study to Characterize Interferon-Induced Gene Expression in Liver Cells and Peripheral Blood Lymphocytes Using High Density Oligonucleotide Microarray Expression Analysis in Caucasian and African American Patients With Chronic Hepatitis C
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555
- The University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Absence of concurrent medical and psychiatric illnesses (e.g. other viral co-infection such as HBV or HIV, renal failure, poorly controlled diabetes, cardiac-pulmonary diseases, CNS disease, active alcoholism, depression, psychosis)
- No history of Type 1 or Type 2 diabetes mellitis
- TSH within normal limits (0.49-4.7 micro IU/ml)
- ANA <1:160
- No history of hepatocellular carcinoma
- Alpha fetoprotein within normal limits (0-20 ng/ml) obtained within 6 months of enrollment.
- If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used with his partner simultaneously while receiving medication, and for 6 months after stopping the medications. The following are considered reliable and effective methods of birth control.
1) Condoms with or without a spermicidal agent 2) Diaphragm or cervical cap with spermicide 3) IUD 4) Hormonal-based contraception 16. Exceptions may include if study participant/partner is surgically sterile 17. Willingness to comply with procedures and treatment as outlined in the protocols and provide written informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
Other Study ID Numbers
- 04-014
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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