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

May 6, 2012 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Novartis Investigative Site
      • Christchurch, New Zealand
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: LCQ908
Drug: LCQ908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure: Change in hepatitis C viral load as assessed by PCR
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.
Time Frame: 28 days
28 days
Measure: LCQ908 concentrations in the blood
Time Frame: over 21 days
over 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCQ908A2214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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