NCT01387958

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

July 1, 2011

Last Update Submit

May 6, 2012

Conditions

Hepatitis C

Keywords

Hepatitis C virusChronically infectedtreatment naivenon responders to prior therapy

Outcome Measures

Primary Outcomes (1)

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

    2 weeks

Secondary Outcomes (2)

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

    28 days

  • Measure: LCQ908 concentrations in the blood

    over 21 days

Study Arms (2)

LCQ908

EXPERIMENTAL
Drug: LCQ908

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LCQ908DRUG
LCQ908
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of other investigational drugs within at least 30 days of enrollment
  • Women of child-bearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Auckland, New Zealand

Location

Novartis Investigative Site

Christchurch, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 27788579DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

pradigastat

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 6, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

NZ(2)