A Phase 2 interventional study of EBR/GZR FDC Tablet and Placebo in HCV Infection, sponsored by Merck Sharp & Dohme LLC. Completed at 15 sites in 4 countries. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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Among 92 studies in Hepatitis C by Merck & Co., Inc — none open to participants now, none under way, none of them phase 3. Hepatitis C · Merck & Co., Inc.
Among the 92 studies in Hepatitis C by Merck & Co., Inc, this one is the 37th largest by enrollment of the 69 interventional ones that give a count, is one of 2 that started in 2018, is one of 20 in phase 2, and was the 91st registered.
1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.
Browse Hepatitis C studies →None of the 92 studies in Hepatitis C by Merck & Co., Inc is open now. The open studies under Hepatitis C, anywhere →
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 3 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
92 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 26 · Phase 3 13 · Phase 4 5
First in 1997; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is below the median of 73 across 1,224 interventional studies indexed under Hepatitis C.
Median enrollment 60 across the 69 interventional studies, 332 across the 23 observational. Of the 86 that completed or were terminated, 66 (77%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 92 studies in Hepatitis C by Merck & Co., Inc, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric hepatitis C virus (HCV)-infected participants who are 3 to \<18 years of age. Within each age cohort (Cohort 1: 12 to \<18 years of age; Cohort 2: 7 to \<12 years of age; and Cohort 3: 3 to \<7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric granules instead of a tablet.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric participants receive EBR/GZR as either FDC tablets or oral granules once daily for 12 weeks. A 24-week follow-up period will follow the 12-week treatment regimen.
Drug: EBR/GZR FDC Tablet · Drug: Placebo · Drug: Grazoprevir Oral Granules · Drug: Elbasvir Oral Granules
Drug page: MK-5172A
Participants who are 12 to \<18 years of age will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily by mouth.
Also known as: MK-5172A, ZEPATIER®
Placebo tablet matched to EBR/GZR FDC tablet.
Participants 3 to \<12 years of age take grazoprevir granules 0.5 mg by mouth in a soft food vehicle at a dose not to exceed 50 mg.
Also known as: MK-5172
Participants 3 to \<12 years of age take elbasvir oral granules 1 mg by mouth in a soft food vehicle at a dose not to exceed 100 mg.
Also known as: MK-8742
Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State
The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Maximum Plasma Concentration (Cmax) of EBR
The Cmax of EBR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Steady State Predose Drug Concentration (Ctrough) of EBR
The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Time frame: Week 4: Predose
Apparent Clearance (CL/F) of EBR at Steady State
The CL/F of EBR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
AUC0-24hr of GZR at Steady State
The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax of GZR
The Cmax of GZR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Ctrough of GZR
The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Time frame: Week 4: Predose
CL/F of GZR at Steady State
The CL/F of GZR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Percentage of Participants With ≥1 Adverse Event (AE)
The percentage of participants with ≥1 AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 36 weeks
Percentage of Participants Discontinuing Study Treatment Due to an AE
The percentage of participants discontinuing study therapy due to an AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
The percentage of participants achieving SVR12, defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after completing study therapy, was determined in each cohort.
Time frame: Week 24
Male and female participants 3 to \<18 years of age with chronic hepatitis C virus (HCV) genotype 1 (GT1) or GT4 were enrolled at 14 global study sites.
| Milestone | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Started | 22 | 17 | 7 | 11 |
| Completed | 22 | 17 | 7 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort.
| µM*hr | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State | 2.41 (1.97 to 2.94) | 2.79 (2.31 to 3.37) | 1.71 (1.36 to 2.15) | 3.15 (2.52 to 3.96) |
The Cmax of EBR at steady state (Week 4) was determined in each cohort.
| µM | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of EBR | 0.19 (0.15 to 0.23) | 0.21 (0.17 to 0.25) | 0.14 (0.11 to 0.19) | 0.28 (0.22 to 0.36) |
The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
| nM | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Steady State Predose Drug Concentration (Ctrough) of EBR | 59.76 (47.20 to 75.67) | 59.43 (48.67 to 72.58) | 34.61 (28.00 to 42.77) | 68.92 (54.32 to 87.44) |
The CL/F of EBR at steady state (Week 4) was determined in each cohort.
| L/hr | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Apparent Clearance (CL/F) of EBR at Steady State | 23.53 (19.25 to 28.75) | 12.21 (10.10 to 14.75) | 9.94 (7.89 to 12.53) | 8.98 (7.16 to 11.27) |
The percentage of participants with ≥1 AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Percentage of Participants | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Percentage of Participants With ≥1 Adverse Event (AE) | 81.8 | 76.5 | 85.7 | 81.8 |
The percentage of participants discontinuing study therapy due to an AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Percentage of Participants | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Percentage of Participants Discontinuing Study Treatment Due to an AE | 0.0 | 0.0 | 0.0 | 0.0 |
The percentage of participants achieving SVR12, defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after completing study therapy, was determined in each cohort.
| Percentage of Participants | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12) | 100.0 (84.6 to 100.0) | 100.0 (80.5 to 100.0) | 100.0 (59.0 to 100.0) | 100.0 (71.5 to 100.0) |
The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
| µM*hr | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| AUC0-24hr of GZR at Steady State | 1.45 (1.08 to 1.94) | 1.42 (1.00 to 2.02) | 0.77 (0.48 to 1.23) | 1.66 (1.16 to 2.39) |
The Cmax of GZR at steady state (Week 4) was determined in each cohort.
| µM | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Cmax of GZR | 0.25 (0.17 to 0.35) | 0.19 (0.12 to 0.31) | 0.09 (0.05 to 0.18) | 0.29 (0.18 to 0.47) |
The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
| nM | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded |
|---|---|---|---|---|
| Ctrough of GZR | 16.20 (12.27 to 21.38) | 16.27 (11.97 to 22.10) | 13.79 (9.55 to 19.90) | 16.17 (12.78 to 20.45) |
The CL/F of GZR at steady state (Week 4) was determined in each cohort.
No measurements were reported for this outcome.
Collected over Up to 36 weeks for nonserious AEs (NSAEs) and serious AEs (SAEs), and up to approximately 49 weeks for all-cause mortality.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Age Cohort 1: 12 to < 18 Years | 0/22 (0%) | 1/22 (4.5%) | 17/22 (77.3%) |
| Age Cohort 2: 7 to < 12 Years | 0/17 (0%) | 0/17 (0%) | 13/17 (76.5%) |
| Age Cohort 3 Mini: 3 to < 7 Years | 0/7 (0%) | 0/7 (0%) | 6/7 (85.7%) |
| Age Cohort 3 Expanded: 3 to < 7 Years | 0/11 (0%) | 1/11 (9.1%) | 9/11 (81.8%) |
| Event | Age Cohort 1: 12 to < 18 Years | Age Cohort 2: 7 to < 12 Years | Age Cohort 3 Mini: 3 to < 7 Years | Age Cohort 3 Expanded: 3 to < 7 Years |
|---|---|---|---|---|
| DyspepsiaGastrointestinal disorders | 0/22 | 0/17 | 0/7 | 1/11 |
| Hand fractureInjury, poisoning and procedural complications | 1/22 | 0/17 | 0/7 | 0/11 |
| Event | Age Cohort 1: 12 to < 18 Years | Age Cohort 2: 7 to < 12 Years | Age Cohort 3 Mini: 3 to < 7 Years | Age Cohort 3 Expanded: 3 to < 7 Years |
|---|---|---|---|---|
| HeadacheNervous system disorders | 8/22 | 2/17 | 0/7 | 2/11 |
| VomitingGastrointestinal disorders | 3/22 | 1/17 | 0/7 | 3/11 |
| Respiratory tract infectionInfections and infestations | 0/22 | 2/17 | 1/7 | 3/11 |
| Upper respiratory tract infectionInfections and infestations | 0/22 | 3/17 | 1/7 | 3/11 |
| ConstipationGastrointestinal disorders | 1/22 | 0/17 | 1/7 | 2/11 |
| NauseaGastrointestinal disorders | 4/22 | 0/17 | 0/7 | 0/11 |
| BronchitisInfections and infestations | 0/22 | 0/17 | 1/7 | 2/11 |
| NasopharyngitisInfections and infestations | 4/22 | 1/17 | 1/7 | 1/11 |
| Abdominal painGastrointestinal disorders | 1/22 | 1/17 | 1/7 | 0/11 |
| DiarrhoeaGastrointestinal disorders | 1/22 | 1/17 | 1/7 | 0/11 |
| Age, Continuous(Years) | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded | Total |
|---|---|---|---|---|---|
| Mean | 14.1 ± 1.9 | 8.7 ± 1.2 | 3.7 ± 0.8 | 4.8 ± 1.3 | 9.4 ± 4.4 |
| Sex: Female, Male(Participants) | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded | Total |
|---|---|---|---|---|---|
| Female | 11 | 7 | 3 | 8 | 29 |
| Male | 11 | 10 | 4 | 3 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 1 | 0 | 6 |
| Not Hispanic or Latino | 19 | 14 | 6 | 11 | 50 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Age Cohort 3: 3 to <7 Years: Mini | Age Cohort 3: 3 to <7 Years: Expanded | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 21 | 17 | 7 | 11 | 56 |
| More than one race | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Jan 2018 to primary completion in Oct 2019, 21 months.
Results were first posted in Aug 2020, 9 months after primary completion.
Of 48 industry-sponsored phase 2 interventional studies under Hepatitis C, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 26. This study's 21 months is above that.
Counting every sponsor, half of 61 studies reached it within 19 months; a quarter within 13 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: MK-5172A