Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)
|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: NCT02204475|
Recruitment Status : Withdrawn
First Posted : July 30, 2014
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Grazoprevir/Elbasvir Drug: Boceprevir Drug: PegIntron Drug: Ribavarin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Boceprevir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 Infection|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||September 2016|
Active Comparator: BOC/PR
All participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks.
Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.
Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.
Other Name: Pegylated Interferon
Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.
Participants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks.
Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).
- Proportion of participants achieving SVR12 [ Time Frame: Up to Week 60 ]
- Proportion of TN participants achieving SVR12 [ Time Frame: Up to Week 60 ]
- Number of participants experiencing an adverse event (AE) [ Time Frame: Up to Week 72 ]
- Number of participants withdrawing from study treatment due to AEs [ Time Frame: Up to Week 72 ]
- Proportion of PTF participants achieving SVR12 [ Time Frame: Up to Week 60 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204475
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|