Back to resultsDouble-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
Primary Purpose
Chronic Hepatitis C (HCV)
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX184
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C (HCV) focused on measuring Hepatitis C, HCV, treatment-naive
Eligibility Criteria
Inclusion criteria:
- 18-65 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
Exclusion criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Cohort C
Cohort D
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
Measures how much virus is in the blood.
Full Information
NCT ID
NCT00807001
First Posted
December 10, 2008
Last Updated
August 18, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00807001
Brief Title
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
Official Title
A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C (HCV)
Keywords
Hepatitis C, HCV, treatment-naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IDX184
Intervention Description
oral dose, active or placebo
Primary Outcome Measure Information:
Title
Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Description
Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening
Time Frame
17 days
Secondary Outcome Measure Information:
Title
Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
Description
Measures how much virus is in the blood.
Time Frame
Baseline to 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
18-65 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
Exclusion criteria:
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)
12. IPD Sharing Statement
Citations:
PubMed Identifier
23070151
Citation
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.
Results Reference
result
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Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
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