Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01825980

Run by

Novartis Pharmaceuticals

People needed

54

Starts

2013-03-01

Expected to finish

2014-12-01

Last updated by the study team

2021-02-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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