Clinical Trial Results:
3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
Summary
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EudraCT number |
2012-005636-29 |
Trial protocol |
BG |
Global end of trial date |
20 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Mar 2016
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First version publication date |
31 Mar 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MK-1894-009
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01721265 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Idenix Protocol Number: IDX-03YF | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Mar 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Mar 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
All participants in this study have previously been in an Idenix hepatitis C virus (HCV) study and received study drug for 3 consecutive days. Participants who had received placebo in a previous Idenix study will not be enrolled in this study.
In this study, researchers will try to find answers to these questions:
•How much (if any) HCV is in your blood after stopping your Idenix study drug?
•Is your HCV possibly resistant to treatment with the Idenix study drug or similar drugs?
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Sep 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 1
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Country: Number of subjects enrolled |
Israel: 6
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Country: Number of subjects enrolled |
United States: 138
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Worldwide total number of subjects |
145
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EEA total number of subjects |
1
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
138
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Adult male and female participants who participated in an Idenix study and received ≥3 doses of a direct-acting antiviral (DAA) were recruited for this 3-year observational follow-up study. | ||||||||||||||||
Pre-assignment
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Screening details |
A total of 145 participants were drawn from Idenix studies IDX-06A-001 (n=17), IDX-06A-005 (n=78), IDX-08C-004 (n=16), and IDX-08C-005 (n=34). | ||||||||||||||||
Period 1
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Period 1 title |
3-Year Observational Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Blinding implementation details |
This was an unblinded observational follow-up study.
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Arms
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Arm title
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Prior Idenix DAA Treatment | ||||||||||||||||
Arm description |
Adult male and female participants who had previously participated in an Idenix HCV study in which they had previously received ≥3 doses of a DAA. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
MK-2355
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Investigational medicinal product code |
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Other name |
IDX184
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants who took ≥3 consecutive daily doses of MK-2355 in an earlier study were followed in the current study.
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Investigational medicinal product name |
MK-1894
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Investigational medicinal product code |
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Other name |
IDX719
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants who took ≥3 consecutive daily doses of MK-1894 in an earlier study were followed in the current study.
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Baseline characteristics reporting groups
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Reporting group title |
Prior Idenix DAA Treatment
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Reporting group description |
Adult male and female participants who had previously participated in an Idenix HCV study in which they had previously received ≥3 doses of a DAA. | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Prior Idenix DAA Treatment
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Reporting group description |
Adult male and female participants who had previously participated in an Idenix HCV study in which they had previously received ≥3 doses of a DAA. |
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End point title |
Number of participants with HCV RNA <LLoQ [1] | ||||||||||||||||||||||||||||
End point description |
The number of participants with HCV ribonucleic acid (RNA) below the lower limit of quantification (LLoQ) at consecutive 3-month intervals after prior IDX DAA treatment was determined. Plasma HCV RNA was assessed using the Roche COBAS Taqman 96 assay v.2.0, which has a LLoQ of 15 IU/mL.
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End point type |
Primary
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End point timeframe |
Months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Per protocol, only descriptive statistics were presented. |
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No statistical analyses for this end point |
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End point title |
Kinetics of resistance associated variants (RAVs) | ||||||
End point description |
The kinetics of RAVs to IDX DAAs in participants who were virologic failures in the initial studies, or had relapsed in this study, were to be analyzed. However, analysis of RAVs was not performed due to early termination of this study.
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End point type |
Secondary
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End point timeframe |
Months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30
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Notes [2] - Analysis of RAVs was not performed due to early study termination. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Safety data (including adverse events) were not collected and therefore no analysis was planned.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
Not applicable | ||
Dictionary version |
N/A
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Safety data (including adverse events) were not collected and therefore no analysis was planned. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |