Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)
A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2012
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedOctober 14, 2015
October 1, 2015
6 months
February 2, 2012
October 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA.
Days 7-12.
Study Arms (4)
Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV
EXPERIMENTAL800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV
EXPERIMENTAL100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment.
Main Pt.1: 800 mg Grazoprevir
EXPERIMENTAL800 mg Grazoprevir.
Procedural Pilot
EXPERIMENTALOptimization of FNA procedure.
Interventions
Polyethyleneglycolated Interferon alfa-2b at 1.5 ug/kg/week, administered subcutaneously, once a week, over the entire course of the study.
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.
Tissue samples are collected at 1 of six possible visits by core needle biopsy (CNB) of the liver.
Blood is collected from multiple blood draws, with the total volume for each participant not expected to exceed 500 ml.
Ribavirin, 600-1400 mg administered orally, twice daily, over the entire course of the study.
800 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
100 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
Tissue samples from the liver are collected by CNB as part of standard of care, and also by FNA during a single visit.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2012
First Posted
March 7, 2012
Study Start
May 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
October 14, 2015
Record last verified: 2015-10