An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepati
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| City: |
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San Antonio |
| State: |
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Texas |
| Zip Code: |
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78215 |
| 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 agents (DAAs) and Ribavirin (RBV) in
subjects with chronic Hepatitis C Virus (HCV).
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria
- Chronic hepatitis C, genotype 1 infection (IL28B rs12979860 genotype C/C).
- 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
Hepatitis C Virus.
- Treatment naïve male or female between the ages of 18 and 65.
- Females must be post-menopausal for at least 2 years or surgically sterile.
- Be in a condition of general good health, as perceived by the investigator, other
than Hepatitis C Virus infection.
Exclusion Criteria
- Significant sensitivity to any drug.
- Use of herbal supplements within 2 weeks prior to study drug dosing.
- Positive screen for drugs and alcohol.
- Positive Hepatitis surface Antigen and anti-Human Immunodeficiency Virus Antibody.
- Use of CYP3A, CYP2C8, and OATP1B1 enzyme inducers or inhibitors within 1 month of
dosing.
- Prior treatment with any investigational or commercially available anti-Hepatitis C
Virus agents.
- Abnormal laboratory tests.
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| NCT ID: |
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NCT01221298 |
| Primary Contact: |
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Study Director
Daniel Cohen, MD
Abbott
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| Backup Contact: |
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N/A |
| Location Contact: |
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San Antonio, Texas 78215
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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