Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
CBZF961X2201
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
2 other identifiers
interventional
54
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 3, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 21, 2021
February 1, 2021
1.8 years
April 3, 2013
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
HCV viral load
Viral load samples will be taken at Day 3.
Day 3
Secondary Outcomes (2)
Number of participants with adverse events as a measure of safety
2 weeks
Total BZF961 concentration in plasma
Day 4
Study Arms (2)
BZF961
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.
Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Novartis Investigative Site
San Diego, California, 92120, United States
Novartis Investigative Site
Orlando, Florida, 32809, United States
Novartis Investigative Site
San Antonio, Texas, 78215, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2013
First Posted
April 8, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 21, 2021
Record last verified: 2021-02