Trial record 1 of 4 for:
merck mk5172 hiv
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02105662 |
Recruitment Status :
Completed
First Posted : April 7, 2014
Results First Posted : March 4, 2016
Last Update Posted : February 5, 2021
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Chronic Hepatitis C |
Intervention |
Drug: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets |
Enrollment | 218 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 218 participants were enrolled and treated on study, 212 participants completed 24 weeks of follow-up. |
Arm/Group Title | Grazoprevir+Elbasvir |
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Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks. |
Period Title: Overall Study | |
Started | 218 |
Completed | 212 |
Not Completed | 6 |
Reason Not Completed | |
Lost to Follow-up | 5 |
Withdrawal by Subject | 1 |
Baseline Characteristics
Arm/Group Title | Grazoprevir+Elbasvir | |
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Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks. | |
Overall Number of Baseline Participants | 218 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 218 participants | |
48.7 (8.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 218 participants | |
Female |
35 16.1%
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Male |
183 83.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp. |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT02105662 |
Other Study ID Numbers: |
5172-061 2014-000342-30 ( EudraCT Number ) |
First Submitted: | April 2, 2014 |
First Posted: | April 7, 2014 |
Results First Submitted: | February 3, 2016 |
Results First Posted: | March 4, 2016 |
Last Update Posted: | February 5, 2021 |