NCT00807001

Brief Summary

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_1

Status
completed

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

Study Start

First participant enrolled

December 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 4, 2010

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

December 10, 2008

Results QC Date

October 8, 2010

Last Update Submit

August 18, 2016

Conditions

Chronic Hepatitis C (HCV)

Keywords

Hepatitis C, HCV, treatment-naive

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events

    Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening

    17 days

Secondary Outcomes (1)

  • Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)

    Baseline to 4 days

Study Arms (4)

Cohort A

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.

Drug: IDX184

Cohort B

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.

Drug: IDX184

Cohort C

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.

Drug: IDX184

Cohort D

EXPERIMENTAL

Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.

Drug: IDX184

Interventions

IDX184DRUG

oral dose, active or placebo

Cohort ACohort BCohort CCohort D

Eligibility Criteria

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

You may qualify if:

  • years old
  • Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
  • Plasma HCV RNA ≥ 5 log10 IU/mL
  • HCV genotype 1

You may not qualify if:

  • Received prior antiviral treatment for hepatitis C infection
  • Subject is pregnant or breastfeeding
  • Body Mass Index (BMI) \> 32
  • Currently abusing alcohol or illicit drugs
  • Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
  • Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15.

    PMID: 23070151RESULT

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

IDX184

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Adverse events summarized the 3 days of IDX184 dosing and 14 days of treatment free follow up.

Results Point of Contact

Title
John Z. Sullivan-Bolyai, MD, MPH
Organization
Idenix Pharmaceuticals, Inc.
877-433-6491

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 19, 2016

Results First Posted

November 4, 2010

Record last verified: 2016-08