Hepatitis CPhase 3NCT02204475
Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)
A Phase 3 study testing Grazoprevir/Elbasvir, Boceprevir and PegIntron in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. 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, Boceprevir and PegIntron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 at the time of screening
- Has documented chronic HCV GT 1 with no evidence of non-typeable or mixed GT infection
- Is cirrhotic or non-cirrhotic
- Has HCV treatment status that is treatment naïve, PR null responder; PR partial responder; or prior PR relapser
- If human immunodeficiency virus (HIV) co-infected (HIV-1) must be naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART treatment while participating in this trial, or be on HIV ART for at least 8 weeks prior to trial entry (no changes in HIV regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of HIV virologic failure and the development of antiretroviral drug resistance
- Use an acceptable method of contraception or not be of childbearing potential
Who cannot join
- Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
- Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive)
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
- Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- Has pre-existing psychiatric condition(s)
- Has clinically-relevant drug or alcohol abuse within 12 months of screening
Show all 10Show fewer
- Is a female and is pregnant or breast-feeding, or expecting to become pregnant or donate eggs from Day 1 throughout treatment and until at least 6 months after the last dose of study medication, or longer if dictated by local regulations; or is a male subject and is planning to impregnate or provide sperm donation
- Has any preexisting condition or prestudy laboratory abnormality, electrocardiogram (ECG) abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering the study drug(s) to the subject
- Has a life-threatening severe AE (SAE) during the screening period
- Has evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
About this study
Official title: A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Boceprevir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 Infection
This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.
- Conditions
- Hepatitis C
- Being tested
- Grazoprevir/Elbasvir, Boceprevir, PegIntron, Ribavarin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazoprevir/ElbasvirDrug
Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).
BoceprevirDrug
Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.
PegIntronDrug
Also called Pegylated Interferon
Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.
RibavarinDrug
Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.
| Study group | Role | What they receive |
|---|---|---|
| BOC/PR | Active comparator | All participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks. Receives: Drug: Boceprevir; Drug: PegIntron; Drug: Ribavarin |
| Grazoprevir/Elbasvir | Experimental | Participants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks. Receives: Drug: Grazoprevir/Elbasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving SVR12
Measured: Up to Week 60
Secondary outcomes (4)
Proportion of TN participants achieving SVR12
Measured: Up to Week 60
Number of participants experiencing an adverse event (AE)
Measured: Up to Week 72
Number of participants withdrawing from study treatment due to AEs
Measured: Up to Week 72
Proportion of PTF participants achieving SVR12
Measured: Up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204475
- Sponsor's protocol ID
- 5172-066
- Other IDs
- 2014-001841-25, 2014
- Status last verified
- Oct 2015
- First submitted
- 28 Jul 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Boceprevir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 Infection
- ClinicalTrials.gov ID
- NCT02204475
- Acronym / sponsor ID
- 5172-066
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOC/PR | Active comparator | Drug: Boceprevir, Drug: PegIntron, Drug: RibavarinAll participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks. |
| Grazoprevir/Elbasvir | Experimental | Drug: Grazoprevir/ElbasvirParticipants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has HCV RNA ≥ 10,000 IU/mL at the time of screening
- Has documented chronic HCV GT 1 with no evidence of non-typeable or mixed GT infection
- Is cirrhotic or non-cirrhotic
- Has HCV treatment status that is treatment naïve, PR null responder; PR partial responder; or prior PR relapser
- If human immunodeficiency virus (HIV) co-infected (HIV-1) must be naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART treatment while participating in this trial, or be on HIV ART for at least 8 weeks prior to trial entry (no changes in HIV regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of HIV virologic failure and the development of antiretroviral drug resistance
Key exclusion criteria (10 listed)
- Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
- Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive)
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
- Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- Has pre-existing psychiatric condition(s)
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 |
|---|---|---|
| Grazoprevir/ElbasvirParticipants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO). | Drug | Grazoprevir/Elbasvir |
| BoceprevirParticipants take Boceprevir (BOC) 800 mg three times daily (TID) PO. | Drug | BOC/PR |
| PegIntronAlso: Pegylated InterferonParticipants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection. | Drug | BOC/PR |
| RibavarinParticipants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO. | Drug | BOC/PR |
Primary outcome
Proportion of participants achieving SVR12
Time frame: Up to Week 60
4 secondary outcomes
Proportion of TN participants achieving SVR12
Time frame: Up to Week 60
Number of participants experiencing an adverse event (AE)
Time frame: Up to Week 72
Number of participants withdrawing from study treatment due to AEs
Time frame: Up to Week 72
Proportion of PTF participants achieving SVR12
Time frame: Up to Week 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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 3 study testing Grazoprevir/Elbasvir, Boceprevir and PegIntron 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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants achieving SVR12 (time frame: Up to Week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.