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

Hepatitis C Clinical Trial

— CBZF961X2201  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825980
• Other study ID #: CBZF961X2201
• Secondary ID: 2012-003103-35
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• BZF961
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
Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV viral load	Viral load samples will be taken at Day 3.	Day 3
Secondary	Number of participants with adverse events as a measure of safety		2 weeks
Secondary	Total BZF961 concentration in plasma		Day 4

External Links

•   Results for CBZF9612201 from the Novartis Clinical Trials website