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NCT01716156

A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)

Completed Phase 2 Results posted Last updated 24 September 2018
What this trial tests

Phase 2 trial testing Grazoprevir in Hepatitis C in 26 participants. Completed in 12 March 2014.

Timeline
18 January 2013
Primary endpoint
9 December 2013
12 March 2014

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment26
Start date18 January 2013
Primary completion9 December 2013
Estimated completion12 March 2014

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) Primary · Up to Week 36

SVR12 was defined as HCV RNA \<25 IU/mL 12 weeks after the end of all study therapy. 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.

GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks58.327.7 – 84.8
Grazoprevir 100 mg + RBV 24 Weeks90.055.5 – 99.7
Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study Primary · Fourteen days following last dose of study drug (up to 26 weeks)

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 clinicall

GroupValue95% CI
Grazoprevir 100 mg + RBV: up to 12 Weeks72.7
Grazoprevir 100 mg + RBV: Beyond 12 Weeks86.7
Percentage of Participants Discontinuing Study Therapy Due to an AE Primary · Up to 24 weeks

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 clinicall

GroupValue95% CI
Grazoprevir 100 mg + RBV: up to 12 Weeks0
Grazoprevir 100 mg + RBV: Beyond 12 Weeks0
Time to Achievement of First Undetectable HCV RNA Secondary · Up to Week 24

The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. 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 below the limit of detection of 9.3 IU/mL.

GroupValue95% CI
Grazoprevir 100 mg + RBV HCV GT1a27.1± 2.5
Grazoprevir 100 mg + RBV HCV GT1non-a19.7± 2.8
Percentage of Participants With Undetectable HCV RNA by Time Point Secondary · From Week 2 through end of treatment (up to 24 weeks)

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 (End of Treatment Response). 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 below the limit of detection of 9.3 IU/mL.

Week 2
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks50.015.7 – 84.3
Grazoprevir 100 mg + RBV 12 Weeks Extended0.00.0 – 60.2
Grazoprevir 100 mg + RBV 24 Weeks41.715.2 – 72.3
Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended0.00.0 – 60.2
Grazoprevir 100 mg + RBV 24 Weeks81.848.2 – 97.7
Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended75.019.4 – 99.4
Grazoprevir 100 mg + RBV 24 Weeks81.848.2 – 97.7
End of all therapy
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended75.019.4 – 99.4
Grazoprevir 100 mg + RBV 24 Weeks91.761.5 – 99.8
Percentage of Participants With HCV RNA <25 IU/mL by Time Point Secondary · From Week 2 through end of treatment (up to 24 weeks)

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 (End of Treatment Response). 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 below the limit of detection of 9.3 IU/mL.

Week 2
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended75.019.4 – 99.4
Grazoprevir 100 mg + RBV 24 Weeks100.073.5 – 100.0
Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended100.039.8 – 100.0
Grazoprevir 100 mg + RBV 24 Weeks100.071.5 – 100.0
Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended75.019.4 – 99.4
Grazoprevir 100 mg + RBV 24 Weeks90.958.7 – 99.8
End of all therapy
GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks100.063.1 – 100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended75.019.4 – 99.4
Grazoprevir 100 mg + RBV 24 Weeks91.761.5 – 99.8
Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4) Secondary · Up to Week 28

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 4 weeks after the end of all study therapy.

GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks87.547.3 – 99.7
Grazoprevir 100 mg + RBV 12 Weeks Extended75.019.4 – 99.4
Grazoprevir 100 mg + RBV 24 Weeks90.958.7 – 99.8
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24) Secondary · Up to Week 48

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 24 weeks after the end of all study therapy.

GroupValue95% CI
Grazoprevir 100 mg + RBV 12 Weeks62.524.5 – 91.5
Grazoprevir 100 mg + RBV 12 Weeks Extended50.06.8 – 93.2
Grazoprevir 100 mg + RBV 24 Weeks80.044.4 – 97.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 26 weeks (from first day of treatment, Day 1, through Day 14 of follow-up). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Grazoprevir 100 mg + RBV: Beyond 12 Weeks
Serious: 0/15 (0%)
Deaths: —
Grazoprevir 100 mg + RBV: up to 12 Weeks
Serious: 0/11 (0%)
Deaths: —
Other adverse events (54 terms — click to expand)

ReactionSystemGrazoprevir 100 mg + RBV: …Grazoprevir 100 mg + RBV: …
AstheniaGeneral disorders——
HeadacheNervous system disorders——
FatigueGeneral disorders——
InsomniaPsychiatric disorders——
Muscle spasmsMusculoskeletal and connective tissue disorders——
CoughRespiratory, thoracic and mediastinal disorders——
AnaemiaBlood and lymphatic system disorders——
Abdominal pain lowerGastrointestinal disorders——
DyspepsiaGastrointestinal disorders——
NauseaGastrointestinal disorders——
Musculoskeletal painMusculoskeletal and connective tissue disorders——
HypertensionVascular disorders——
Chest painGeneral disorders——
ChillsGeneral disorders——
IrritabilityGeneral disorders——
PyrexiaGeneral disorders——
Affective disorderPsychiatric disorders——
DepressionPsychiatric disorders——
Accidental overdoseInjury, poisoning and procedural complications——
Aspartate aminotransferase increasedInvestigations——
Blood creatine phosphokinase increasedInvestigations——
Weight decreasedInvestigations——
PalpitationsCardiac disorders——
EpistaxisRespiratory, thoracic and mediastinal disorders——
Oropharyngeal painRespiratory, thoracic and mediastinal disorders——
DizzinessNervous system disorders——
Eye inflammationEye disorders——
Ear painEar and labyrinth disorders——
Abdominal painGastrointestinal disorders——
ConstipationGastrointestinal disorders——
Dry mouthGastrointestinal disorders——
DiarrhoeaGastrointestinal disorders——
FlatulenceGastrointestinal disorders——
Frequent bowel movementsGastrointestinal disorders——
Gastrooesophageal reflux diseaseGastrointestinal disorders——
Lip dryGastrointestinal disorders——
Paraesthesia oralGastrointestinal disorders——
VomitingGastrointestinal disorders——
HaematuriaRenal and urinary disorders——
Dry skinSkin and subcutaneous tissue disorders——

Data from ClinicalTrials.gov NCT01716156 adverse events section.

Sponsor's own description

This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1 infection.
    Gane E, Ben Ari Z, Mollison L, Zuckerman E, et al · · 2016 · cited 10× · PMID 27291249 · DOI 10.1111/jvh.12552
  2. Characterization of hepatitis C virus resistance to grazoprevir reveals complex patterns of mutations following on-treatment breakthrough that are not observed at relapse.
    Bonsall D, Black S, Howe AY, Chase R, et al · · 2018 · cited 7× · PMID 30127629 · DOI 10.2147/idr.s156581

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Other trials of Grazoprevir

Trials testing the same drug.

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Trials by the same sponsor.

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