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

Primary Purpose

Hepatitis C

Status

Terminated

Phase

Phase 2

Locations

New Zealand

Study Type

Interventional

Intervention

LCQ908

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C virus, Chronically infected, treatment naive, non responders to prior therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LCQ908

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Measure: Change in hepatitis C viral load as assessed by PCR

Secondary Outcome Measures

Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.

Measure: LCQ908 concentrations in the blood

Full Information

NCT ID

NCT01387958

First Posted

July 1, 2011

Last Updated

May 6, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01387958

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Terminated

Why Stopped

Terminated early due to futility

Study Start Date

July 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C virus, Chronically infected, treatment naive, non responders to prior therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCQ908

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LCQ908

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Measure: Change in hepatitis C viral load as assessed by PCR

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.

Time Frame

28 days

Title

Measure: LCQ908 concentrations in the blood

Time Frame

over 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Auckland

Country

New Zealand

Facility Name

Novartis Investigative Site

City

Christchurch

Country

New Zealand

12. IPD Sharing Statement

Citations:

PubMed Identifier

27788579

Citation

Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis. 2017 Feb 10;3(2):144-151. doi: 10.1021/acsinfecdis.6b00138. Epub 2016 Nov 8.

Results Reference

derived

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

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