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Hepatitis CPhase 2NCT02601573

Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)

A Phase 2 study testing Grazoprevir, Elbasvir and Ribavirin in people with Hepatitis C, 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

This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Grazoprevir, Elbasvir and Ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
No sites listed yet
Study dates
5 Jan 2016to 6 Jan 2017
Phase
Phase 2
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

  • has HCV RNA (>= 10,000 IU/mL in peripheral blood) at screening
  • has documented HCV GT3 (with no evidence of non-typeable or mixed GT infection)
  • has compensated cirrhosis of the liver
  • has liver imaging within 6 months of Day 1 with no evidence of hepatocellular carcinoma (HCC)
  • is either HCV TN or TE (i.e., has documented prior virologic failure or intolerance to peg-interferon/ribavirin)
  • is otherwise healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements
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  • has compensated cirrhosis of the liver
  • is TN or TE (i.e., documented prior virologic failure or intolerance to peg-interferon/ribavirin)
  • is not of reproductive potential, or agrees to not impregnate a partner or become pregnant for at least 2 weeks prior to the first dose of study drug, and for 7 months after the final dose of study drug (or longer if dictated by local regulations)

Who cannot join

  • has previously received one or more doses of a direct-acting antiviral (DAA)
  • has evidence of decompensated liver disease
  • is coinfected with hepatitis B (hepatitis B surface antigen [HBsAg] positive)
  • has a recent (within 5 years) history of malignancy or is under evaluation for HCC or other suspected malignancy
  • is currently or has participated (within past 30 days) in a study with an investigational compound
  • has clinically-relevant drug or alcohol abuse within the past 12 months of screening
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  • is a female and is pregnant or breast-feeding
  • is a male whose female partner is/are pregnant
  • has any of the following:
  • organ transplants
  • poor venous access
  • history of gastric surgery or malabsorption disorder
  • current or history of clinically significant cardiac abnormalities or dysfunction
  • chronic pulmonary disease
  • hemoglobinopathy
  • history of hospitalization within 3 months prior to enrollment
  • medical or surgical condition that may result in need for hospitalization during the course of the study
  • any condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppresant drugs during the course of the study
  • any condition, prestudy laboratory or ECG abnormality, or history of any illness, which could confound results of the study or pose additional risks in administering study drugs in the opinion of the investigator
  • has a life-threatening serious AE (SAE) during the screening period
  • has evidence of history of chronic hepatitis not caused by HCV

About this study

Official title: A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection

This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.

Conditions
Hepatitis C
Being tested
Grazoprevir, Elbasvir, Ribavirin, Sofosbuvir
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

    GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.

  • ElbasvirDrug

    Also called MK-8742

    EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

  • RibavirinDrug

    Also called Rebetol®

    RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).

  • SofosbuvirDrug

    Also called Sovaldi®, Harvoni®

    SOF 400 mg tablet taken q.d. by mouth in the morning with food.

Study groups in NCT02601573
Study groupRoleWhat they receive
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 WeeksExperimentalTN HCV GT3 participants will take 1 fixed-dose combination (FDC) tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg once-daily (q.d.) with RBV (200 mg capsules; weight-based dosing) twice-daily (b.i.d.) for 8 weeks.
Receives: Drug: Grazoprevir; Drug: Elbasvir; Drug: Ribavirin; Drug: Sofosbuvir
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 WeeksExperimentalTN HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
Receives: Drug: Grazoprevir; Drug: Elbasvir; Drug: Sofosbuvir
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 WeeksExperimentalTE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
Receives: Drug: Grazoprevir; Drug: Elbasvir; Drug: Sofosbuvir
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 WeeksExperimentalTE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
Receives: Drug: Grazoprevir; Drug: Elbasvir; Drug: Ribavirin; Drug: Sofosbuvir
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 WeeksExperimentalTE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Receives: Drug: Grazoprevir; Drug: Elbasvir; Drug: Sofosbuvir

What is being measured

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

  1. Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)

    The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.

    Measured: Up to Week 28

  2. Percentage of Participants Experiencing an Adverse Event (AE)

    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.

    Measured: Up to 18 weeks (up to 2 weeks after completion of study treatment)

  3. Percentage of Participants Discontinuing From Study Therapy Due to an AE

    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.

    Measured: Up to 16 weeks

Secondary outcomes (1)

  1. Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)

    The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.

    Measured: Up to Week 40

Timeline

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

  1. First posted10 Nov 2015 (estimated)
  2. Study start5 Jan 2016
  3. Primary completion18 Oct 2016
  4. Study completion6 Jan 2017

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02601573
Sponsor's protocol ID
5172-083
Other IDs
2015-003187-37, MK-5172-083, 2015
Status last verified
Aug 2019
First submitted
9 Nov 2015
Last updated
13 Aug 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Foster GR, Agarwal K, Cramp ME, Moreea S, Barclay S, Collier J, Brown AS, Ryder SD, Ustianowski A, Forton DM, Fox R, Gordon F, Rosenberg WM, Mutimer DJ, Du J, Gilbert CL, Asante-Appiah E, Wahl J, Robertson MN, Barr E, Haber B. Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial. Hepatology. 2018 Jun;67(6):2113-2126. doi: 10.1002/hep.29852. Epub 2018 Apr 19.

    PubMed 29473975

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Grazoprevir, Elbasvir and Ribavirin in people with Hepatitis C, 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 9 inclusion and 21 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 13 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Nov 2017). 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 Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy) (time frame: Up to Week 28). 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 NCT02601573, 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 13 Aug 2019.

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