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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014