Trial · NCT01667081
Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
NCT01667081, Completed, Merck Sharp & Dohme LLC; results first posted 2022-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017). Trials, record NCT01667081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01667081
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
- NCT number
- NCT01667081
- Status
- Completed
- Enrollment
- 2,438 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C
- Interventions
- Grazoprevir
- First posted
- 2012-08-17
- Last updated
- 2022-06-06
- Other registries' IDs
- eudract:2012-002232-85
- Results first posted
- 2022-06-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Viral Relapse | Up to ~60 months after enrollment in this study | Viral relapse is defined as any participant who has confirmed HCV Ribonucleic acid (RNA) ≥ Lower limit of quantification (LLoQ) of 15 IU/mL and had achieved sustained virologic response (SVR) in the follow up in the prior treatment study. Time to relapse is defined as the time from last dose of study therapy taken in the prior treatment study until the date where HCV RNA is ≥LLoQ. |
| Primary | Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | Up to ~60 months after enrollment in this study | In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time. |
| Primary | Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections | Up to ~60 months after enrollment in this study | In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time. |
| Primary | Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections | Up to ~60 months after enrollment in this study | In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time. |
| Primary | Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up | Up to ~ 60 months after enrollment in this study | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The study investigator determined whether the adverse event was drug-related. |
| Primary | Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up | Up to ~60 months after enrollment in this study | A serious adverse event (SAE) is any adverse experience occurring at any dose that either results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose (whether accidental or intentional), or other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed previously. The study investigator determined whether the adverse event was drug-related. |
| Primary | Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up | Up to ~60 months after enrollment in this study | An ECI includes spontaneous bacterial peritonitis, variceal bleeding, ascites, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver transplant, cardiovascular disease limited to angina and myocardial infarction, neurologic disorders limited to transient ischemic attack (TIA) or stroke, graft rejection in participants who have undergone liver or kidney transplant, or one of the following in participants from the MK-5172-052 (NCT02092350) base study: kidney transplant, decreased estimated glomerular filtration rate (eGFR), new onset diabetes, cryoglobulinemia, or post transplantation glomerulonephritis. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Viral Relapse | Up to ~60 months after enrollment in this study | All participants who achieved SVR during the follow-up period of the prior treatment study and did not start any new HCV therapy between the end of the prior treatment study and entry in this study | Months | MEDIAN |
| PRIMARY | Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | Up to ~60 months after enrollment in this study | Participants met the criteria of virologic failure either in the prior base study or had HCV RNA Target detected, quantifiable \[TD(q)\] at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections | Up to ~60 months after enrollment in this study | Participants met the criteria of virologic failure either in the prior base study or had HCV RNA TD(q) at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections | Up to ~60 months after enrollment in this study | Participants met the criteria of virologic failure either in the prior base study or had HCV RNA TD(q) at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up | Up to ~ 60 months after enrollment in this study | All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up | Up to ~60 months after enrollment in this study | All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up | Up to ~60 months after enrollment in this study | All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Viral Relapse | GZR 100 mg + EBR 50 mg +/- RBV | NA | Inter-Quartile Range NA to NA | Months | |
| Time to Viral Relapse | Other GZR Regimen | NA | Inter-Quartile Range NA to NA | Months | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | EBR/GZR +/- RBV: NS3 RASs | Failure | 22 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | EBR/GZR +/- RBV: NS5A RASs | Failure | 25 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | EBR/GZR +/-RBV: Both NS3 and NS5A RASs | Failure | 18 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | GZR + Pegylated Interferon/Ribavirin (PR): NS3 RASs | Failure | 11 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | EBR/GZR +/- RBV: NS3 RASs | 24 weeks post failure | 10 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | EBR/GZR +/- RBV: NS5A RASs | 24 weeks post failure | 25 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | EBR/GZR +/-RBV: Both NS3 and NS5A RASs | 24 weeks post failure | 8 | Participants | |
| Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections | GZR + Pegylated Interferon/Ribavirin (PR): NS3 RASs | 24 weeks post failure | 2 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Grazoprevir (GZR) 100 mg + Elbasvir (EBR) 50 mg +/- Ribavirin (RBV) | 1,909 | |
| Overall Study | STARTED | Other GZR Regimen | 526 | |
| Overall Study | COMPLETED | Grazoprevir (GZR) 100 mg + Elbasvir (EBR) 50 mg +/- Ribavirin (RBV) | 132 | |
| Overall Study | COMPLETED | Other GZR Regimen | 169 | |
| Overall Study | NOT COMPLETED | Grazoprevir (GZR) 100 mg + Elbasvir (EBR) 50 mg +/- Ribavirin (RBV) | 1,777 | |
| Overall Study | NOT COMPLETED | Other GZR Regimen | 357 |
Source ClinicalTrials.gov
Adverse events165
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute coronary syndrome | Cardiac disorders | GZR 100 mg + EBR 50 mg +/- RBV | 2 | 1,909 | 2 |
| serious | Acute coronary syndrome | Cardiac disorders | Other GZR Regimen | 0 | 526 | 0 |
| serious | Acute coronary syndrome | Cardiac disorders | Non-GZR Regimen | 0 | ||
| serious | Acute myocardial infarction | Cardiac disorders | GZR 100 mg + EBR 50 mg +/- RBV | 1 | 1,909 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Other GZR Regimen | 0 | 526 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Non-GZR Regimen | 0 | ||
| serious | Angina pectoris | Cardiac disorders | GZR 100 mg + EBR 50 mg +/- RBV | 1 | 1,909 | 1 |
| serious | Angina pectoris | Cardiac disorders | Other GZR Regimen | 0 | 526 | 0 |
| serious | Angina pectoris | Cardiac disorders | Non-GZR Regimen | 0 | ||
| serious | Angina unstable | Cardiac disorders | GZR 100 mg + EBR 50 mg +/- RBV | 1 | 1,909 | 1 |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GZR 100 mg + EBR 50 mg +/- RBV | 44 | 1,909 |
| Total, all-cause mortality | Other GZR Regimen | 3 | 527 |
| Total, all-cause mortality | Non-GZR Regimen | 0 | 2 |
| Total, other adverse events | GZR 100 mg + EBR 50 mg +/- RBV | 0 | 1,909 |
| Total, other adverse events | Other GZR Regimen | 0 | 526 |
| Total, other adverse events | Non-GZR Regimen | 0 | 0 |
| Total, serious adverse events | GZR 100 mg + EBR 50 mg +/- RBV | 100 | 1,909 |
| Total, serious adverse events | Other GZR Regimen | 4 | 526 |
| Total, serious adverse events | Non-GZR Regimen | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30038064 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GZR 100 mg + EBR 50 mg +/- RBV vs Other GZR Regimen: Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up | Trial comparisons |
| GZR 100 mg + EBR 50 mg +/- RBV vs Other GZR Regimen: Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up | Trial comparisons |
| GZR 100 mg + EBR 50 mg +/- RBV vs Other GZR Regimen: Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01667081
GET https://conductscience.org/api/trials/v1/NCT01667081/results?page=2