A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072 - NCT01074008-32803(Clinical Trial 592930)
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Orlando |
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State:
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FL |
| Zip Code: |
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32803 |
| Conditions: |
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Hepatitis C - HCV - Chronic Hepatitis C - Hepatitis C Genotype 1 |
| Purpose: |
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A 12-week study of combination direct-acting antiviral agent (DAA) and pegIFN/RBV in
subjects with chronic HCV.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Chronic hepatitis C, genotype 1 infection (HCV RNA level greater than or equal to
100,000 IU/mL) at screening.
- Liver biopsy within 3 years with histology consistent with HCV-induced liver damage,
with no evidence of cirrhosis or liver pathology due to any cause other than chronic
HCV.
- Treatment naïve male or female between the ages of 18 and 65.
- Females must be post-menopausal for more than 2 years or surgically sterile.
- Negative screen for drugs and alcohol.
- Negative HBsAg and anti-HIV Ab.
- No use of CYP3A and CYP2C8 enzyme inducers or inhibitors within 1 month of dosing.
- Be in a condition of general good health, as perceived by the investigator, other
than HCV infection.
Exclusion Criteria:
- Significant sensitivity to any drug.
- Use of herbal supplements within 2 weeks prior to study drug dosing. History of
major depression within 2 years.
- Prior treatment with any investigational or commercially available anti-HCV agents.
- Abnormal laboratory tests (see protocol for specifics). |
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| Study is available at: |
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Site Reference ID/Investigator# 23369
Orlando, FL 32803
United States
Primary Contact:
Christian Naylor
Email: christian.naylor@abbott.com
Phone: (847) 935-2492 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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