Chronic Hepatitis CPhase 1NCT01547312
Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)
A Phase 1 study testing Peg-Interferon, Liver Samples from FNA and Liver Samples from CNB in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peg-Interferon, Liver Samples from FNA and Liver Samples from CNB
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Nov 2012
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has chronic compensated HCV infection.
- No contraindications to CNB or FNA procedures.
- Pilot study only: All comers with chronic HCV already scheduled to undergo CNB for fibrosis staging.
- Pilot study only: Requires a diagnostic liver biopsy to monitor progression of liver disease.
- Pilot study only: Does not have cirrhosis.
- Main study only: Males or non-pregnant and postmenopausal females willing to use medically acceptable contraception during, and for 6 months or longer after study.
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- Main study only: Body mass index of 18.5 - 32.0 kg/m^2.
- Main study only: Can avoid aspirin, anticoagulants, and non steroidal inflammatory agents.
- Main study only: Has undergone prior treatment or is treatment naive for chronic HCV infection.
Who cannot join
- History of any of the following: stroke, chronic seizures, major neurological disorders, gastric bypass surgery or bowel resection.
- No viral response to prior interferon based therapy.
- Prior treatment for HCV with an NS3/4A protease inhibitor.
- History of either clinically significant, uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
- History of neoplastic or myeloproliferative disease.
- Has any of the following : cirrhosis, decompensated liver disease, or other advanced liver disease, hepatocellular carcinoma, infection with human immunodeficiency virus (HIV), or hepatitis B.
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- Evidence of high grade bridging fibrosis from prior liver biopsy or chronic hepatitis not caused by HCV.
- History of illicit drug use or alcohol abuse.
- Had surgery, donated at least one unit of blood, or participated in any other investigational study within 4 weeks prior to screening visit.
- History of multiple and/or severe allergies.
About this study
Official title: A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C
This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot, core needle biopsy (CNB) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than FNA be conducted. The second segment, the main study, is designed to evaluate the feasibility of measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other additional procedures will be conducted.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peg-Interferon, Liver Samples from FNA, Liver Samples from CNB, Blood Samples, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-InterferonDrug
Also called PegIntron
Polyethyleneglycolated Interferon alfa-2b at 1.5 ug/kg/week, administered subcutaneously, once a week, over the entire course of the study.
Liver Samples from FNAProcedure or surgery
Tissue samples are collected at 3 separate visits, with each collection consisting of 3-4 fine needle aspiration (FNA) passes through the liver, guided by ultrasound.
Liver Samples from CNBProcedure or surgery
Tissue samples are collected at 1 of six possible visits by core needle biopsy (CNB) of the liver.
Blood SamplesProcedure or surgery
Blood is collected from multiple blood draws, with the total volume for each participant not expected to exceed 500 ml.
RibavirinDrug
Also called Rebetol
Ribavirin, 600-1400 mg administered orally, twice daily, over the entire course of the study.
800 mg GrazoprevirDrug
800 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
100 mg GrazoprevirDrug
100 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
Liver samples from CNB and FNAProcedure or surgery
Tissue samples from the liver are collected by CNB as part of standard of care, and also by FNA during a single visit.
| Study group | Role | What they receive |
|---|---|---|
| Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV | Experimental | 800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment. Receives: Drug: Peg-Interferon; Procedure: Liver Samples from FNA; Procedure: Liver Samples from CNB; Procedure: Blood Samples; Drug: Ribavirin; Drug: 800 mg Grazoprevir |
| Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV | Experimental | 100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment. Receives: Drug: Peg-Interferon; Procedure: Liver Samples from FNA; Procedure: Liver Samples from CNB; Procedure: Blood Samples; Drug: Ribavirin; Drug: 100 mg Grazoprevir |
| Main Pt.1: 800 mg Grazoprevir | Experimental | 800 mg Grazoprevir. Receives: Procedure: Liver Samples from FNA; Procedure: Liver Samples from CNB; Procedure: Blood Samples; Drug: 800 mg Grazoprevir |
| Procedural Pilot | Experimental | Optimization of FNA procedure. Receives: Procedure: Liver samples from CNB and FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA.
Measured: Days 7-12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547312
- Sponsor's protocol ID
- 5172-022
- Other IDs
- 2011-004978-29
- Status last verified
- Oct 2015
- First submitted
- 2 Feb 2012
- Last updated
- 14 Oct 2015
- Results posted
- 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 Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01547312
- Acronym / sponsor ID
- 5172-022
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 7 Mar 2012 (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 study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot, core needle biopsy (CNB) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than FNA be conducted. The second segment, the main study, is designed to evaluate the feasibility of measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other additional procedures will be conducted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV | Experimental | Drug: Peg-Interferon, Procedure: Liver Samples from FNA, Procedure: Liver Samples from CNB, Procedure: Blood Samples, Drug: Ribavirin, Drug: 800 mg Grazoprevir800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment. |
| Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV | Experimental | Drug: Peg-Interferon, Procedure: Liver Samples from FNA, Procedure: Liver Samples from CNB, Procedure: Blood Samples, Drug: Ribavirin, Drug: 100 mg Grazoprevir100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment. |
| Main Pt.1: 800 mg Grazoprevir | Experimental | Procedure: Liver Samples from FNA, Procedure: Liver Samples from CNB, Procedure: Blood Samples, Drug: 800 mg Grazoprevir800 mg Grazoprevir. |
| Procedural Pilot | Experimental | Procedure: Liver samples from CNB and FNAOptimization of FNA procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has chronic compensated HCV infection.
- No contraindications to CNB or FNA procedures.
- Pilot study only: All comers with chronic HCV already scheduled to undergo CNB for fibrosis staging.
- Pilot study only: Requires a diagnostic liver biopsy to monitor progression of liver disease.
- Pilot study only: Does not have cirrhosis.
Key exclusion criteria (10 listed)
- History of any of the following: stroke, chronic seizures, major neurological disorders, gastric bypass surgery or bowel resection.
- No viral response to prior interferon based therapy.
- Prior treatment for HCV with an NS3/4A protease inhibitor.
- History of either clinically significant, uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
- History of neoplastic or myeloproliferative disease.
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 |
|---|---|---|
| Peg-InterferonAlso: PegIntronPolyethyleneglycolated Interferon alfa-2b at 1.5 ug/kg/week, administered subcutaneously, once a week, over the entire course of the study. | Drug | Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV, Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV |
| Liver Samples from FNATissue samples are collected at 3 separate visits, with each collection consisting of 3-4 fine needle aspiration (FNA) passes through the liver, guided by ultrasound. | Procedure or surgery | Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV, Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV, Main Pt.1: 800 mg Grazoprevir |
| Liver Samples from CNBTissue samples are collected at 1 of six possible visits by core needle biopsy (CNB) of the liver. | Procedure or surgery | Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV, Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV, Main Pt.1: 800 mg Grazoprevir |
| Blood SamplesBlood is collected from multiple blood draws, with the total volume for each participant not expected to exceed 500 ml. | Procedure or surgery | Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV, Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV, Main Pt.1: 800 mg Grazoprevir |
| RibavirinAlso: RebetolRibavirin, 600-1400 mg administered orally, twice daily, over the entire course of the study. | Drug | Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV, Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV |
| 800 mg Grazoprevir800 mg Grazoprevir administered orally, once per day, for 7 consecutive days. | Drug | Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV, Main Pt.1: 800 mg Grazoprevir |
| 100 mg Grazoprevir100 mg Grazoprevir administered orally, once per day, for 7 consecutive days. | Drug | Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV |
| Liver samples from CNB and FNATissue samples from the liver are collected by CNB as part of standard of care, and also by FNA during a single visit. | Procedure or surgery | Procedural Pilot |
Primary outcome
Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA.
Time frame: Days 7-12.
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.
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 1 study testing Peg-Interferon, Liver Samples from FNA and Liver Samples from CNB in people with Chronic 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 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 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?
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?
Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA. (time frame: Days 7-12.). 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; AzTrials last refreshed its copy on 8 Nov 2026.