A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients

This study has been terminated.
(Terminated early due to futility)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01387958
First received: July 1, 2011
Last updated: May 6, 2012
Last verified: May 2012
  Purpose

This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.


Condition Intervention Phase
Hepatitis C
Drug: LCQ908
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Change in hepatitis C viral load as assessed by PCR [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Measure: LCQ908 concentrations in the blood [ Time Frame: over 21 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCQ908 Drug: LCQ908
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387958

Locations
New Zealand
Novartis Investigative Site
Auckland, New Zealand
Novartis Investigative Site
Christchurch, New Zealand
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01387958     History of Changes
Other Study ID Numbers: CLCQ908A2214
Study First Received: July 1, 2011
Last Updated: May 6, 2012
Health Authority: New Zealand: Medsafe

Keywords provided by Novartis:
Hepatitis C virus
Chronically infected
treatment naive
non responders to prior therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014