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Trial record 95 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)

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ClinicalTrials.gov Identifier: NCT01710501
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : March 4, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C (CHC)
Interventions Drug: Grazoprevir
Biological: pegylated interferon alfa-2b
Drug: Ribavirin
Drug: Placebo
Enrollment 87
Recruitment Details  
Pre-assignment Details Of 136 screened participants, 87 were randomized to treatment at 19 sites worldwide.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Period Title: Overall Study
Started 29 28 30
Completed 27 28 30
Not Completed 2 0 0
Reason Not Completed
Lost to Follow-up             2             0             0
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV Total
Hide Arm/Group Description After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. Total of all reporting groups
Overall Number of Baseline Participants 29 28 30 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 28 participants 30 participants 87 participants
52.0  (7.9) 48.5  (12.5) 46.4  (13.3) 48.9  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
Female
8
  27.6%
18
  64.3%
15
  50.0%
41
  47.1%
Male
21
  72.4%
10
  35.7%
15
  50.0%
46
  52.9%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)
Hide Description Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.
Time Frame 12 weeks after end of treatment (up to 36 weeks total)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 24 25 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.2
(32.8 to 74.4)
84.0
(63.9 to 95.5)
88.5
(69.8 to 97.6)
2.Primary Outcome
Title Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.
Time Frame 14 days following last dose of study drug (up to 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 29 28 30
Measure Type: Number
Unit of Measure: participants
28 28 28
3.Primary Outcome
Title Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days
Hide Description An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
APaT Population; all randomized participants who received at least one dose of study treatment.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 29 28 30
Measure Type: Number
Unit of Measure: participants
1 1 1
4.Secondary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point
Hide Description HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL.
Time Frame From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 29 26 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 (n=29, 25, 29)
34.5
(17.9 to 54.3)
32.0
(14.9 to 53.5)
55.2
(35.7 to 73.6)
Week 4 (n=28, 26, 29)
82.1
(63.1 to 93.9)
76.9
(56.4 to 91.0)
89.7
(72.6 to 97.8)
Week 12 (n=28, 26, 28)
96.4
(81.7 to 99.9)
92.3
(74.9 to 99.1)
100.0
(87.7 to 100.0)
End of All Therapy (n=26, 25, 26)
92.3
(74.9 to 99.1)
92.0
(74.0 to 99.0)
100.0
(86.8 to 100.0)
5.Secondary Outcome
Title Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point
Hide Description HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.
Time Frame From TW 2 through end of treatment (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 29 26 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 (n=29, 25, 29)
86.2
(68.3 to 96.1)
88.0
(68.8 to 97.5)
96.6
(82.2 to 99.9)
Week 4 (n=28, 26, 29)
96.4
(81.7 to 99.9)
100.0
(86.8 to 100.0)
100.0
(88.1 to 100.0)
Week 12 (n=28, 26, 28)
96.4
(81.7 to 99.9)
100.0
(86.8 to 100.0)
100.0
(87.7 to 100.0)
End of all Therapy (n=26, 25, 26)
92.3
(74.9 to 99.1)
100.0
(86.3 to 100.0)
100.0
(86.8 to 100.0)
6.Secondary Outcome
Title Percentage of Participants Achieving SVR4
Hide Description HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.
Time Frame 4 weeks after end of treatment (up to 28 weeks total)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 26 25 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.9
(56.4 to 91.0)
88.0
(68.8 to 97.5)
92.3
(74.9 to 99.1)
7.Secondary Outcome
Title Percentage of Subjects Achieving SVR24
Hide Description HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.
Time Frame 24 weeks after end of treatment (up to 48 weeks total)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 24 25 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.2
(32.8 to 74.4)
84.0
(63.9 to 95.5)
84.6
(65.1 to 95.6)
8.Secondary Outcome
Title Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response
Hide Description Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.
Time Frame From Day 1 up to Follow-up Week 24 (up to 48 weeks total)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description:
After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Overall Number of Participants Analyzed 12 7 4
Measure Type: Number
Unit of Measure: participants
9 5 3
Time Frame From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks)
Adverse Event Reporting Description AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.
 
Arm/Group Title Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Hide Arm/Group Description After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
All-Cause Mortality
Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      2/28 (7.14%)      0/30 (0.00%)    
Cardiac disorders       
Acute myocardial infarction  1  0/29 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/29 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Grazoprevir 25 mg + PEG-IFN + RBV Grazoprevir 50 mg + PEG-IFN + RBV Grazoprevir 100 mg + PEG-IFN + RBV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/29 (96.55%)      28/28 (100.00%)      27/30 (90.00%)    
Blood and lymphatic system disorders       
Anaemia  1  8/29 (27.59%)  11 11/28 (39.29%)  11 11/30 (36.67%)  11
Leukopenia  1  3/29 (10.34%)  3 0/28 (0.00%)  0 3/30 (10.00%)  5
Monocytosis  1  1/29 (3.45%)  1 0/28 (0.00%)  0 3/30 (10.00%)  3
Neutropenia  1  9/29 (31.03%)  9 4/28 (14.29%)  5 7/30 (23.33%)  12
Thrombocytopenia  1  2/29 (6.90%)  2 1/28 (3.57%)  3 2/30 (6.67%)  3
Eye disorders       
Eye pain  1  1/29 (3.45%)  1 2/28 (7.14%)  2 1/30 (3.33%)  1
Gastrointestinal disorders       
Abdominal distension  1  0/29 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  2
Abdominal pain  1  1/29 (3.45%)  1 4/28 (14.29%)  4 1/30 (3.33%)  1
Aphthous stomatitis  1  2/29 (6.90%)  2 0/28 (0.00%)  0 1/30 (3.33%)  1
Constipation  1  2/29 (6.90%)  2 3/28 (10.71%)  4 3/30 (10.00%)  3
Diarrhoea  1  2/29 (6.90%)  2 7/28 (25.00%)  8 5/30 (16.67%)  5
Dry mouth  1  0/29 (0.00%)  0 3/28 (10.71%)  3 1/30 (3.33%)  1
Dyspepsia  1  1/29 (3.45%)  1 1/28 (3.57%)  1 2/30 (6.67%)  2
Haemorrhoids  1  1/29 (3.45%)  1 3/28 (10.71%)  4 0/30 (0.00%)  0
Nausea  1  11/29 (37.93%)  11 17/28 (60.71%)  18 9/30 (30.00%)  10
Vomiting  1  3/29 (10.34%)  3 1/28 (3.57%)  1 6/30 (20.00%)  6
General disorders       
Asthenia  1  2/29 (6.90%)  2 2/28 (7.14%)  2 3/30 (10.00%)  3
Chest pain  1  2/29 (6.90%)  2 0/28 (0.00%)  0 0/30 (0.00%)  0
Chills  1  13/29 (44.83%)  14 12/28 (42.86%)  12 13/30 (43.33%)  13
Fatigue  1  18/29 (62.07%)  18 17/28 (60.71%)  17 18/30 (60.00%)  19
Feeling cold  1  0/29 (0.00%)  0 2/28 (7.14%)  2 0/30 (0.00%)  0
Influenza like illness  1  6/29 (20.69%)  6 7/28 (25.00%)  7 7/30 (23.33%)  7
Injection site erythema  1  9/29 (31.03%)  9 8/28 (28.57%)  8 7/30 (23.33%)  7
Irritability  1  8/29 (27.59%)  8 2/28 (7.14%)  2 7/30 (23.33%)  8
Malaise  1  1/29 (3.45%)  1 2/28 (7.14%)  2 0/30 (0.00%)  0
Pain  1  3/29 (10.34%)  5 2/28 (7.14%)  2 6/30 (20.00%)  6
Pyrexia  1  10/29 (34.48%)  12 7/28 (25.00%)  7 11/30 (36.67%)  11
Infections and infestations       
Folliculitis  1  2/29 (6.90%)  2 0/28 (0.00%)  0 0/30 (0.00%)  0
Sinusitis  1  0/29 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  4
Urinary tract infection  1  2/29 (6.90%)  2 2/28 (7.14%)  6 0/30 (0.00%)  0
Vulvovaginal mycotic infection  1  0/29 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  2
Injury, poisoning and procedural complications       
Accidental overdose  1  4/29 (13.79%)  4 4/28 (14.29%)  4 1/30 (3.33%)  1
Investigations       
Alanine aminotransferase increased  1  1/29 (3.45%)  1 1/28 (3.57%)  2 3/30 (10.00%)  3
Aspartate aminotransferase increased  1  1/29 (3.45%)  1 1/28 (3.57%)  3 2/30 (6.67%)  2
Blood bilirubin increased  1  0/29 (0.00%)  0 2/28 (7.14%)  4 1/30 (3.33%)  1
Blood creatine phosphokinase increased  1  1/29 (3.45%)  1 0/28 (0.00%)  0 3/30 (10.00%)  4
Red cell distribution width increased  1  1/29 (3.45%)  1 0/28 (0.00%)  0 2/30 (6.67%)  2
Metabolism and nutrition disorders       
Decreased appetite  1  12/29 (41.38%)  12 7/28 (25.00%)  7 14/30 (46.67%)  14
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/29 (17.24%)  6 8/28 (28.57%)  8 1/30 (3.33%)  1
Back pain  1  1/29 (3.45%)  1 2/28 (7.14%)  2 4/30 (13.33%)  5
Muscle spasms  1  0/29 (0.00%)  0 0/28 (0.00%)  0 3/30 (10.00%)  3
Musculoskeletal pain  1  0/29 (0.00%)  0 2/28 (7.14%)  2 3/30 (10.00%)  3
Myalgia  1  11/29 (37.93%)  12 6/28 (21.43%)  7 9/30 (30.00%)  10
Nervous system disorders       
Disturbance in attention  1  1/29 (3.45%)  1 2/28 (7.14%)  2 1/30 (3.33%)  1
Dizziness  1  6/29 (20.69%)  7 5/28 (17.86%)  6 2/30 (6.67%)  2
Dysgeusia  1  2/29 (6.90%)  2 2/28 (7.14%)  2 4/30 (13.33%)  4
Headache  1  10/29 (34.48%)  13 17/28 (60.71%)  19 13/30 (43.33%)  17
Lethargy  1  0/29 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  2
Sinus headache  1  1/29 (3.45%)  1 0/28 (0.00%)  0 2/30 (6.67%)  2
Psychiatric disorders       
Anxiety  1  1/29 (3.45%)  1 2/28 (7.14%)  2 1/30 (3.33%)  1
Depression  1  3/29 (10.34%)  3 3/28 (10.71%)  3 1/30 (3.33%)  2
Insomnia  1  5/29 (17.24%)  5 3/28 (10.71%)  3 4/30 (13.33%)  5
Renal and urinary disorders       
Chromaturia  1  0/29 (0.00%)  0 2/28 (7.14%)  2 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  4/29 (13.79%)  4 3/28 (10.71%)  3 5/30 (16.67%)  6
Dysphonia  1  2/29 (6.90%)  2 0/28 (0.00%)  0 1/30 (3.33%)  1
Dyspnoea  1  5/29 (17.24%)  5 5/28 (17.86%)  5 5/30 (16.67%)  5
Dyspnoea exertional  1  3/29 (10.34%)  3 3/28 (10.71%)  3 4/30 (13.33%)  4
Oropharyngeal pain  1  2/29 (6.90%)  2 1/28 (3.57%)  2 2/30 (6.67%)  3
Skin and subcutaneous tissue disorders       
Dry skin  1  2/29 (6.90%)  2 5/28 (17.86%)  6 3/30 (10.00%)  3
Pruritus  1  5/29 (17.24%)  5 8/28 (28.57%)  9 5/30 (16.67%)  5
Pruritus generalised  1  1/29 (3.45%)  1 0/28 (0.00%)  0 3/30 (10.00%)  3
Rash  1  5/29 (17.24%)  7 5/28 (17.86%)  6 4/30 (13.33%)  5
Rash maculo-papular  1  1/29 (3.45%)  2 0/28 (0.00%)  0 2/30 (6.67%)  2
Alopecia  1  2/29 (6.90%)  2 3/28 (10.71%)  3 3/30 (10.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01710501     History of Changes
Other Study ID Numbers: 5172-038
2012-003333-42 ( EudraCT Number )
First Submitted: October 17, 2012
First Posted: October 19, 2012
Results First Submitted: February 3, 2016
Results First Posted: March 4, 2016
Last Update Posted: September 24, 2018