Hepatitis CPhase 1/2CBZF961X2201NCT01825980
Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
A Phase 1/2 study testing BZF961 and Ritonavir in people with Hepatitis C, run by Novartis Pharmaceuticals at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- What is being tested?
- BZF961 and Ritonavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Novartis Investigative Site
Orlando, Florida, 32809
Novartis Investigative Site
San Antonio, Texas, 78215
Novartis Investigative Site
San Diego, California, 92120
About this study
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
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.
- Conditions
- Hepatitis C
- Being tested
- BZF961, Ritonavir, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BZF961Drug
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.
RitonavirDrug
Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BZF961 | Experimental | Not described Receives: Drug: BZF961; Drug: Ritonavir |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV viral load
Viral load samples will be taken at Day 3.
Measured: Day 3
Secondary outcomes (2)
Number of participants with adverse events as a measure of safety
Measured: 2 weeks
Total BZF961 concentration in plasma
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825980
- Sponsor's protocol ID
- CBZF961X2201
- Other IDs
- 2012-003103-35
- Acronym
- CBZF961X2201
- Status last verified
- Feb 2021
- First submitted
- 3 Apr 2013
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01825980
- Acronym / sponsor ID
- CBZF961X2201 / CBZF961X2201
- Conditions
- Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BZF961 | Experimental | Drug: BZF961, Drug: Ritonavir |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BZF961There 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. | Drug | BZF961 |
| RitonavirRitonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961 | Drug | BZF961 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
HCV viral load
Time frame: Day 3
Viral load samples will be taken at Day 3.
2 secondary outcomes
Number of participants with adverse events as a measure of safety
Time frame: 2 weeks
Total BZF961 concentration in plasma
Time frame: Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Results for CBZF9612201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BZF961 and Ritonavir in people with Hepatitis C, run by Novartis Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV viral load (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.