Hepatitis C VirusPhase 2/3C-SURFERNCT02092350

Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)

A Phase 2/3 study testing Grazoprevir and Elbasvir in people with Hepatitis C Virus, 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus
What is being tested?: Grazoprevir and Elbasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 237 participants
Where: No sites listed yet
Study dates: 17 Mar 2014to 2 Sep 2015
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
Evidence or no evidence of liver cirrhosis based on one of the following:
Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
Fibroscan performed within 12 months of Day 1 of this study
Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI] obtained during the screening period)
Has HCV status that is one of the following:

Show all 11Show fewer

Treatment naïve
Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser)
Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen
Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations

Who cannot join

Evidence of decompensated liver disease
On peritoneal dialysis for management of kidney disease
Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
History of malignancy <=5 years prior to signing informed consent
Clinical diagnosis of substance abuse
Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations

Show all 14Show fewer

Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
Uncontrolled or poorly controlled hypertension
Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent
New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent
Severe active peripheral vascular disease
Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
Evidence or history of chronic hepatitis not caused by HCV

About this study

Official title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease

This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.

Conditions: Hepatitis C Virus
Being tested: Grazoprevir, Elbasvir, Placebo to Grazoprevir, Placebo to Elbasvir
Medical subject headings: Hepatitis C

What participants receive

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

GrazoprevirDrug
Also called MK-5172
Grazoprevir 100 mg tablet
ElbasvirDrug
Also called MK-8742
Elbasvir 50 mg tablet
Placebo to GrazoprevirDrug
Placebo tablet matched to grazoprevir
Placebo to ElbasvirDrug
Placebo tablet matched to elbasvir

Study groups in NCT02092350
Study group	Role	What they receive
Immediate Treatment	Experimental	Participants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks. Receives: Drug: Grazoprevir; Drug: Elbasvir
Deferred Treatment	Experimental	Participants receive placebos to both grazoprevir and elbasvir for 12 weeks, and after a 4-week break, grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks. Receives: Drug: Grazoprevir; Drug: Elbasvir; Drug: Placebo to Grazoprevir; Drug: Placebo to Elbasvir
Intensive PK	Experimental	Participants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing. Receives: Drug: Grazoprevir; Drug: Elbasvir

What is being measured

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

Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Measured: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Measured: Up to Week 14
Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Measured: Up to Week 12

Secondary outcomes (2)

Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Measured: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)
SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Measured: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)

Timeline

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

17 Mar 20142 Sep 2015

First posted20 Mar 2014 (estimated)
Study start17 Mar 2014
Primary completion11 Mar 2015
Study completion2 Sep 2015

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 (6)Papers the sponsor has linked to this study.
Other trials for Hepatitis C VirusStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02092350
Sponsor's protocol ID: 5172-052
Other IDs: 2013-003858-25
Acronym: C-SURFER
Status last verified: Aug 2018
First submitted: 17 Mar 2014
Last updated: 24 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Roth D, Nelson DR, Bruchfeld A, Liapakis A, Silva M, Monsour H Jr, Martin P, Pol S, Londono MC, Hassanein T, Zamor PJ, Zuckerman E, Wan S, Jackson B, Nguyen BY, Robertson M, Barr E, Wahl J, Greaves W. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015 Oct 17;386(10003):1537-45. doi: 10.1016/S0140-6736(15)00349-9. Epub 2015 Oct 5.
PubMed 26456905
Bruchfeld A, Roth D, Martin P, Nelson DR, Pol S, Londono MC, Monsour H Jr, Silva M, Hwang P, Arduino JM, Robertson M, Nguyen BY, Wahl J, Barr E, Greaves W. Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):585-594. doi: 10.1016/S2468-1253(17)30116-4. Epub 2017 May 30.
PubMed 28576451
Prabhu AR, Rao IR, Nagaraju SP, Rajwar E, Venkatesh BT, Nair N S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD007003. doi: 10.1002/14651858.CD007003.pub3.
PubMed 37096802
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
Reau N, Robertson MN, Feng HP, Caro L, Yeh WW, Nguyen BT, Wahl J, Barr E, Hwang P, Klopfer SO. Concomitant proton pump inhibitor use does not reduce the efficacy of elbasvir/grazoprevir: A pooled analysis of 1,322 patients with hepatitis C infection. Hepatol Commun. 2017 Aug 22;1(8):757-764. doi: 10.1002/hep4.1081. eCollection 2017 Oct.
PubMed 29404492
Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.
PubMed 28193518

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

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All Hepatitis C Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
ClinicalTrials.gov ID: NCT02092350
Acronym / sponsor ID: C-SURFER / 5172-052
Conditions: Hepatitis C Virus
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 237 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 Mar 2014 (actual)
Primary completion: 11 Mar 2015 (actual)
Study completion: 2 Sep 2015 (actual)
First posted: 20 Mar 2014 (estimated)
Results: Posted 12 Apr 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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Immediate Treatment	Experimental	Drug: Grazoprevir, Drug: ElbasvirParticipants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks.
Deferred Treatment	Experimental	Drug: Grazoprevir, Drug: Elbasvir, Drug: Placebo to Grazoprevir, Drug: Placebo to ElbasvirParticipants receive placebos to both grazoprevir and elbasvir for 12 weeks, and after a 4-week break, grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks.
Intensive PK	Experimental	Drug: Grazoprevir, Drug: ElbasvirParticipants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
Evidence or no evidence of liver cirrhosis based on one of the following:
Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
Fibroscan performed within 12 months of Day 1 of this study
Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI] obtained during the screening period)

Key exclusion criteria (14 listed)

Evidence of decompensated liver disease
On peritoneal dialysis for management of kidney disease
Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
History of malignancy <=5 years prior to signing informed consent
Clinical diagnosis of substance abuse

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
GrazoprevirAlso: MK-5172Grazoprevir 100 mg tablet	Drug	Deferred Treatment, Immediate Treatment, Intensive PK
ElbasvirAlso: MK-8742Elbasvir 50 mg tablet	Drug	Deferred Treatment, Immediate Treatment, Intensive PK
Placebo to GrazoprevirPlacebo tablet matched to grazoprevir	Drug	Deferred Treatment
Placebo to ElbasvirPlacebo tablet matched to elbasvir	Drug	Deferred Treatment

Primary outcome

Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
Time frame: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods
Time frame: Up to Week 14
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period
Time frame: Up to Week 12
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.

2 secondary outcomes

Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
Time frame: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)
Time frame: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)

Results and safety

Results posted to the registry on 12 Apr 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
Immediate Treatment + Intensive PK	123	113
Deferred Treatment	114	102

Primary outcome: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)

Time frame: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Immediate Treatment + Intensive PK n = 116	Deferred Treatment n = 99
Value	99.1 (95.3 to 100.0)	98.0 (92.9 to 99.8)

Immediate Treatment + Intensive PK: p = 0.001, One-sided exact test

Population analysed: The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.

Primary outcome: Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods

Time frame: Up to Week 14. Number. Unit: Participants

Measure	Immediate Treatment + Intensive PK n = 122	Deferred Treatment n = 113
Value	93	96

Population analysed: The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.

Primary outcome: Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period

Time frame: Up to Week 12. Number. Unit: Participants

Measure	Immediate Treatment + Intensive PK n = 122	Deferred Treatment n = 113
Value	0	5

Population analysed: The APaT population includes all enrolled participants who received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Treatment + Intensive PK	30 of 122 (24.6%)	67 of 122 (54.9%)	Not reported
Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks	22 of 113 (19.5%)	68 of 113 (60.2%)	Not reported
Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks	25 of 102 (24.5%)	39 of 102 (38.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26456905Roth D, Nelson DR, Bruchfeld A, Liapakis A, Silva M, Monsour H Jr, Martin P, Pol S, Londono MC, Hassanein T, Zamor PJ, Zuckerman E, Wan S, Jackson B, Nguyen BY, Robertson M, Barr E, Wahl J, Greaves W. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015 Oct 17;386(10003):1537-45. doi: 10.1016/S0140-6736(15)00349-9. Epub 2015 Oct 5.
Results publication: PubMed 28576451Bruchfeld A, Roth D, Martin P, Nelson DR, Pol S, Londono MC, Monsour H Jr, Silva M, Hwang P, Arduino JM, Robertson M, Nguyen BY, Wahl J, Barr E, Greaves W. Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):585-594. doi: 10.1016/S2468-1253(17)30116-4. Epub 2017 May 30.
Derived from this study: PubMed 37096802Prabhu AR, Rao IR, Nagaraju SP, Rajwar E, Venkatesh BT, Nair N S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD007003. doi: 10.1002/14651858.CD007003.pub3.
Derived from this study: 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.
Derived from this study: PubMed 29404492Reau N, Robertson MN, Feng HP, Caro L, Yeh WW, Nguyen BT, Wahl J, Barr E, Hwang P, Klopfer SO. Concomitant proton pump inhibitor use does not reduce the efficacy of elbasvir/grazoprevir: A pooled analysis of 1,322 patients with hepatitis C infection. Hepatol Commun. 2017 Aug 22;1(8):757-764. doi: 10.1002/hep4.1081. eCollection 2017 Oct.
Derived from this study: PubMed 28193518Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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 2/3 study testing Grazoprevir and Elbasvir in people with Hepatitis C Virus, 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 11 inclusion and 14 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 24 Sep 2018. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Apr 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?

Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (time frame: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)). The study lists 3 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 NCT02092350, which also lists 6 linked publications.

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 24 Sep 2018.