Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/11/2016 |
| Start Date: | March 2013 |
| End Date: | December 2014 |
Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of 3 Days of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus (HCV) Infected Patients
To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability
of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed Male &
female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-1.
Subjects must weight at least 50kg to participate in the study, and must have a body
mass index (BMI) within the range of 18-36 kg/m2 Able to communicate well with the
investigator, to understand and comply with the study requirements.
Exclusion Criteria:
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5
half-lives of enrollment, whichever is longer: or longer if required by local
regulations, and for any other limitation of participation in an investigational
trial based on local regulations.
Subjects that were previously treated for HCV infection.
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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