Hepatitis CPhase 2NCT01716156
A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)
A Phase 2 study testing Grazoprevir and Ribavirin in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). 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 and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2013to 12 Mar 2014
- 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
- Chronic, compensated HCV GT 1 hepatitis C
- IL28B CC genotype
- Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
- No evidence of cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (FibroScan and/or FibroTest)
- Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)
Who cannot join
- Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype
- Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
- Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
- Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
- Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
- Diabetes and/or hypertension with clinically significant ocular examination findings
Show all 24Show fewer
- Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders
- Clinical diagnosis of substance abuse
- Current or history of seizure disorder, stroke, or transient ischemic attack
- Immunologically-mediated disease
- Chronic pulmonary disease
- Clinically significant cardiac abnormalities/dysfunction
- Active clinical gout within the last year
- Hemoglobinopathy or myelodysplastic syndromes
- History of organ transplants
- Poor venous access
- Indwelling venous catheter
- History of gastric surgery or malabsorption disorder
- Severe concurrent disease
- Evidence of active or suspected malignancy, or under evaluation for malignancy, or history of malignancy, within the last 5 years
- Pregnant, lactating, or expecting to conceive or donate eggs
- Male participant whose female partner is pregnant
- Member or a family member of the investigational study staff or sponsor staff directly involved with this study
- History of chronic hepatitis not caused by HCV
About this study
Official title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.
- Conditions
- Hepatitis C
- Being tested
- Grazoprevir, Ribavirin
- 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
Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment
RibavirinDrug
Also called Rebetol™, RBV
Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight
| Study group | Role | What they receive |
|---|---|---|
| Grazoprevir 100 mg + RBV 12 Weeks | Experimental | Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment. Receives: Drug: Grazoprevir; Drug: Ribavirin |
| Grazoprevir 100 mg + RBV 24 Weeks | Experimental | Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Receives: Drug: Grazoprevir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.
Measured: Up to Week 36
Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
Measured: Fourteen days following last dose of study drug (up to 26 weeks)
Percentage of Participants Discontinuing Study Therapy Due to an AE
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
Measured: Up to 24 weeks
Secondary outcomes (5)
Time to Achievement of First Undetectable HCV RNA
The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
Measured: Up to Week 24
Percentage of Participants With Undetectable HCV RNA by Time Point
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
Measured: From Week 2 through end of treatment (up to 24 weeks)
Percentage of Participants With HCV RNA <25 IU/mL by Time Point
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
Measured: From Week 2 through end of treatment (up to 24 weeks)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy.
Measured: Up to Week 28
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy.
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study start18 Jan 2013
- Primary completion9 Dec 2013
- Study completion12 Mar 2014
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716156
- Sponsor's protocol ID
- 5172-039
- Other IDs
- 2012-003340-72
- Status last verified
- Aug 2018
- First submitted
- 25 Oct 2012
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Gane E, Ben Ari Z, Mollison L, Zuckerman E, Bruck R, Baruch Y, Howe AY, Wahl J, Bhanja S, Hwang P, Zhao Y, Robertson MN. Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1 infection. J Viral Hepat. 2016 Oct;23(10):789-97. doi: 10.1111/jvh.12552. Epub 2016 Jun 12.
PubMed 27291249
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 Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01716156
- Acronym / sponsor ID
- 5172-039
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2013 (actual)
- Primary completion
- 9 Dec 2013 (actual)
- Study completion
- 12 Mar 2014 (actual)
- First posted
- 29 Oct 2012 (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.
This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grazoprevir 100 mg + RBV 12 Weeks | Experimental | Drug: Grazoprevir, Drug: RibavirinGrazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment. |
| Grazoprevir 100 mg + RBV 24 Weeks | Experimental | Drug: Grazoprevir, Drug: RibavirinGrazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic, compensated HCV GT 1 hepatitis C
- IL28B CC genotype
- Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
- No evidence of cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (FibroScan and/or FibroTest)
- Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)
Key exclusion criteria (24 listed)
- Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype
- Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
- Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
- Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
- Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
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 |
|---|---|---|
| GrazoprevirGrazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment | Drug | Grazoprevir 100 mg + RBV 12 Weeks, Grazoprevir 100 mg + RBV 24 Weeks |
| RibavirinAlso: Rebetol™, RBVRibavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight | Drug | Grazoprevir 100 mg + RBV 12 Weeks, Grazoprevir 100 mg + RBV 24 Weeks |
Primary outcome
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
Time frame: Up to Week 36
SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.
Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study
Time frame: Fourteen days following last dose of study drug (up to 26 weeks)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
Percentage of Participants Discontinuing Study Therapy Due to an AE
Time frame: Up to 24 weeks
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
5 secondary outcomes
Time to Achievement of First Undetectable HCV RNA
Time frame: Up to Week 24
Percentage of Participants With Undetectable HCV RNA by Time Point
Time frame: From Week 2 through end of treatment (up to 24 weeks)
Percentage of Participants With HCV RNA <25 IU/mL by Time Point
Time frame: From Week 2 through end of treatment (up to 24 weeks)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)
Time frame: Up to Week 28
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)
Time frame: Up to Week 48
Results and safety
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 27291249Gane E, Ben Ari Z, Mollison L, Zuckerman E, Bruck R, Baruch Y, Howe AY, Wahl J, Bhanja S, Hwang P, Zhao Y, Robertson MN. Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1 infection. J Viral Hepat. 2016 Oct;23(10):789-97. doi: 10.1111/jvh.12552. Epub 2016 Jun 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Grazoprevir 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 5 inclusion and 24 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 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 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?
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) (time frame: Up to Week 36). 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 NCT01716156, 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 24 Sep 2018.