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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01387958




Registration number
NCT01387958
Ethics application status
Date submitted
1/07/2011
Date registered
6/07/2011
Date last updated
8/05/2012

Titles & IDs
Public title
A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients
Scientific title
Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients
Secondary ID [1] 0 0
CLCQ908A2214
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LCQ908
Treatment: Drugs - Placebo

Experimental: LCQ908 -

Placebo Comparator: Placebo -


Treatment: Drugs: LCQ908


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measure: Change in hepatitis C viral load as assessed by PCR
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Measure: LCQ908 concentrations in the blood
Timepoint [2] 0 0
over 21 days

Eligibility
Key inclusion criteria
- Written informed consent.

- Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes
1, 2 or 3).

- No prior therapy or inadequate response to therapy for hepatitis C.

- Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of other investigational drugs within at least 30 days of enrollment

- Women of child-bearing potential.

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a proof of concept study, designed to look at the safety and antiviral activity of
LCQ908 in hepatitis C infected patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01387958
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01387958