Status:
COMPLETED
Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatitis C
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01825980
Start Date
March 1 2013
End Date
December 1 2014
Last Update
February 21 2021
Active Locations (3)
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1
Novartis Investigative Site
San Diego, California, United States, 92120
2
Novartis Investigative Site
Orlando, Florida, United States, 32809
3
Novartis Investigative Site
San Antonio, Texas, United States, 78215