Chronic Hepatitis CPhase 1NCT01937975

The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

A Phase 1 study testing Grazoprevir and Elbasvir in people with Chronic Hepatitis C and Renal Impairment, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Hepatitis C, Renal Impairment
What is being tested?: Grazoprevir and Elbasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 6 Sep 2013to 17 Dec 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All Participants
For a female of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method. Females of non-childbearing potential must have undergone a sterilization procedure at least 6 months prior to the first dose
Non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 90 days after stopping the study medication and agree not to donate sperm during this time period Participants with ESRD on HD
Maintained on a stable regimen of HD within 3 months prior to first dosing Participants with Severe Renal Impairment
Estimated glomerular filtration rate (eGFR) at screening is < 30 mL/min/1.73m^2 Healthy Controls
Participant is within ± 10 years of the mean age and within 10% of the mean body mass index of severe renal impairment participants
eGFR at screening is >=80 mL/min/1.73m^2

Who cannot join

All Participants
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease whose current condition is considered unstable
History or presence of alcoholism and drug abuse within the past 6 months
Female participants who are pregnant or lactating
Regular user of any medication (including over the counter) that would significantly alter GFR
Donation of blood or significant blood loss within 56 days prior to the first dose of study medication(s)

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Plasma donation within 7 days prior to the first dose of study medication(s)
A renal transplant or nephrectomy Participants with ESRD or Severe Renal Impairment
Rapidly fluctuating renal function

About this study

Official title: An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency

Conditions: Chronic Hepatitis C, Renal Impairment
Being tested: Grazoprevir, Elbasvir
Medical subject headings: Hepatitis C, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GrazoprevirDrug
100 mg oral tablet administered once a day for 10 days
ElbasvirDrug
50 mg oral tablet administered once a day for 10 days

Study groups in NCT01937975
Study group	Role	What they receive
Participants with End Stage Renal Disease on Hemodialysis	Experimental	Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.. Receives: Drug: Grazoprevir; Drug: Elbasvir
Participants with Severe Renal Impairment	Experimental	Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Receives: Drug: Grazoprevir; Drug: Elbasvir
Healthy Participants	Experimental	Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Receives: Drug: Grazoprevir; Drug: Elbasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Measured: Up to 24 hours postdose
Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Measured: 24 hours postdose
Maximum Plasma Concentration (Cmax) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Measured: Up to 120 hours postdose
Time of Maximum Plasma Concentration (Tmax) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Measured: Up to 120 hours postdose
Apparent Terminal Half-life (T1/2) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10
Measured: Up to 120 hours postdose
Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Measured: Up to 24 hours postdose
Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10
Measured: Up to 24 hours postdose
Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Measured: Up to 24 hours postdose
Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir
Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Measured: 24 hours postdose
Maximum Plasma Concentration (Cmax) of Elbasvir
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Measured: Up to 120 hours postdose
Time of Maximum Plasma Concentration (Tmax) of Elbasvir
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Measured: Up to 120 hours postdose
Apparent Terminal Half-life (T1/2) of Elbasvir
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10
Measured: Up to 120 hours postdose
Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Measured: Up to 24 hours postdose
Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10
Measured: Up to 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201317 Dec 2013

First posted10 Sep 2013 (estimated)
Study start6 Sep 2013
Primary completion17 Dec 2013
Study completion17 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01937975
Sponsor's protocol ID: 5172-050
Status last verified: Jun 2019
First submitted: 4 Sep 2013
Last updated: 12 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Caro L, Wenning L, Feng HP, Guo Z, Du L, Bhagunde P, Fandozzi C, Panebianco D, Marshall WL, Butterton JR, Iwamoto M, Yeh WW. Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment. Eur J Clin Pharmacol. 2019 May;75(5):665-675. doi: 10.1007/s00228-018-2585-3. Epub 2019 Jan 25.
PubMed 30680407

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency
ClinicalTrials.gov ID: NCT01937975
Acronym / sponsor ID: 5172-050
Conditions: Chronic Hepatitis C, Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Sep 2013 (actual)
Primary completion: 17 Dec 2013 (actual)
Study completion: 17 Dec 2013 (actual)
First posted: 10 Sep 2013 (estimated)
Results: Posted 4 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Participants with End Stage Renal Disease on Hemodialysis	Experimental	Drug: Grazoprevir, Drug: ElbasvirParticipants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days..
Participants with Severe Renal Impairment	Experimental	Drug: Grazoprevir, Drug: ElbasvirParticipants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy Participants	Experimental	Drug: Grazoprevir, Drug: ElbasvirHealthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

All Participants
For a female of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method. Females of non-childbearing potential must have undergone a sterilization procedure at least 6 months prior to the first dose
Non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 90 days after stopping the study medication and agree not to donate sperm during this time period Participants with ESRD on HD
Maintained on a stable regimen of HD within 3 months prior to first dosing Participants with Severe Renal Impairment
Estimated glomerular filtration rate (eGFR) at screening is < 30 mL/min/1.73m^2 Healthy Controls

Key exclusion criteria (9 listed)

All Participants
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease whose current condition is considered unstable
History or presence of alcoholism and drug abuse within the past 6 months
Female participants who are pregnant or lactating
Regular user of any medication (including over the counter) that would significantly alter GFR

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Grazoprevir100 mg oral tablet administered once a day for 10 days	Drug	Healthy Participants, Participants with End Stage Renal Disease on Hemodialysis, Participants with Severe Renal Impairment
Elbasvir50 mg oral tablet administered once a day for 10 days	Drug	Healthy Participants, Participants with End Stage Renal Disease on Hemodialysis, Participants with Severe Renal Impairment

Primary outcome

Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir
Time frame: Up to 24 hours postdose
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir
Time frame: 24 hours postdose
Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Maximum Plasma Concentration (Cmax) of Grazoprevir
Time frame: Up to 120 hours postdose
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Time of Maximum Plasma Concentration (Tmax) of Grazoprevir
Time frame: Up to 120 hours postdose
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Apparent Terminal Half-life (T1/2) of Grazoprevir
Time frame: Up to 120 hours postdose
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10
Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir
Time frame: Up to 24 hours postdose
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir
Time frame: Up to 24 hours postdose
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10
Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir
Time frame: Up to 24 hours postdose
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir
Time frame: 24 hours postdose
Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Maximum Plasma Concentration (Cmax) of Elbasvir
Time frame: Up to 120 hours postdose
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Time of Maximum Plasma Concentration (Tmax) of Elbasvir
Time frame: Up to 120 hours postdose
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Apparent Terminal Half-life (T1/2) of Elbasvir
Time frame: Up to 120 hours postdose
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10
Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir
Time frame: Up to 24 hours postdose
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir
Time frame: Up to 24 hours postdose
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10

Results and safety

Results posted to the registry on 4 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With End Stage Renal Disease on Hemodialysis	8	8
Participants With Severe Renal Impairment	8	8
Healthy Participants	8	8

Primary outcome: Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir

Time frame: Up to 24 hours postdose. Geometric mean (95% Confidence Interval). Unit: uM*hr

Measure	Participants With End Stage Renal Disease n = 8	Participants With Severe Renal Impairment: Day 10 n = 8	Healthy Participants: Day 10 n = 8
Day 9	0.969 (0.689 to 1.36)	NA (NA to NA)	NA (NA to NA)
Day 10	0.944 (0.671 to 1.33)	1.88 (1.23 to 2.86)	1.14 (0.843 to 1.54)

Participants With End Stage Renal Disease: Geometric Mean Ratio: 0.97 (90% CI 0.87 to 1.09)
Participants With End Stage Renal Disease vs Healthy Participants: Day 10: Geometric Mean Ratio: 0.85 (90% CI 0.58 to 1.25)
Participants With End Stage Renal Disease vs Healthy Participants: Day 10: Geometric Mean Ratio: 0.83 (90% CI 0.56 to 1.22)

Population analysed: The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.

Primary outcome: Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir

Time frame: 24 hours postdose. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Participants With End Stage Renal Disease n = 8	Participants With Severe Renal Impairment: Day 10 n = 8	Healthy Participants: Day 10 n = 8
Day 9	11.4 (8.16 to 16.1)	NA (NA to NA)	NA (NA to NA)
Day 10	11.3 (8.03 to 15.8)	23.3 (15.4 to 35.2)	14.5 (10.7 to 19.6)

Participants With End Stage Renal Disease: Geometric Mean Ratio: 0.98 (90% CI 0.81 to 1.19)
Participants With End Stage Renal Disease vs Healthy Participants: Day 10: Geometric Mean Ratio: 0.79 (90% CI 0.54 to 1.16)
Participants With End Stage Renal Disease vs Healthy Participants: Day 10: Geometric Mean Ratio: 0.78 (90% CI 0.53 to 1.14)

Primary outcome: Maximum Plasma Concentration (Cmax) of Grazoprevir

Time frame: Up to 120 hours postdose. Geometric mean (95% Confidence Interval). Unit: uM

Measure	Participants With End Stage Renal Disease n = 8	Participants With Severe Renal Impairment: Day 10 n = 8	Healthy Participants: Day 10 n = 8
Day 9	0.141 (0.092 to 0.215)	NA (NA to NA)	NA (NA to NA)
Day 10	0.135 (0.088 to 0.206)	0.255 (0.152 to 0.429)	0.154 (0.106 to 0.224)

Participants With End Stage Renal Disease: Geometric Mean Ratio: 0.96 (90% CI 0.75 to 1.22)
Participants With End Stage Renal Disease vs Healthy Participants: Day 10: Geometric Mean Ratio: 0.92 (90% CI 0.57 to 1.48)
Participants With End Stage Renal Disease vs Healthy Participants: Day 10: Geometric Mean Ratio: 0.88 (90% CI 0.54 to 1.42)

Primary outcome: Time of Maximum Plasma Concentration (Tmax) of Grazoprevir

Time frame: Up to 120 hours postdose. Median (Full Range). Unit: Hours

Measure	Participants With End Stage Renal Disease n = 8	Participants With Severe Renal Impairment: Day 10 n = 8	Healthy Participants: Day 10 n = 8
Day 9	2.00 (1.00 to 6.00)	NA (NA to NA)	NA (NA to NA)
Day 10	2.50 (0.50 to 7.00)	3.00 (0.50 to 6.00)	2.50 (1.00 to 6.00)

Adverse events

Time frame: Up to 14 days after the last dose of study drug (up to 24 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With End Stage Renal Disease on Hemodialysis	0 of 8 (0%)	4 of 8 (50%)	Not reported
Participants With Severe Renal Impairment	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Healthy Participants	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30680407Caro L, Wenning L, Feng HP, Guo Z, Du L, Bhagunde P, Fandozzi C, Panebianco D, Marshall WL, Butterton JR, Iwamoto M, Yeh WW. Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment. Eur J Clin Pharmacol. 2019 May;75(5):665-675. doi: 10.1007/s00228-018-2585-3. Epub 2019 Jan 25.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Grazoprevir and Elbasvir in people with Chronic Hepatitis C and Renal Impairment, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir (time frame: Up to 24 hours postdose). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.