A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-7009 in Chronic Hepatitis C Patients

Withdrawn

• Conditions: chronic hepatitis C; 10047438

• Registration Number: NL-OMON37067
• Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

• Patient is a male or female between 18 to 65 years of age.
• Patient has a Body Mass Index (BMI) >=18.5 kg/m2 and <=32.0 kg/m2.
• Patient has chronic compensated, genotype 1 HCV infection as defined by positive serology for HCV and detectable HCV RNA (>levels >= 10,000 IU/mL) in peripheral blood.
• The patient does not have cirrhosis as confirmed by FibroSure*/FibroTest® and/or local country procedure (e.g. transient elastography/Fibroscan).
• Patient is treatment-naive, or treatment-experienced, with regard to prior treatment for chronic HCV infection, defined as:
Patient has previously been treated with and has tolerated at least 12 weeks of continuous licensed interferon (including pegylated interferon) and ribavirin combination therapy for HCV (patients previously treated with licensed NS3/4A protease inhibitors are not eligible for inclusion) with at least a partial response (>=2-log10 drop in HCV RNA at week 12) and/or patient has previously been treated with investigational products and/or vaccines for chronic HCV infection, other than NS3/4A protease inhibitors, either alone or in combination with other licensed therapies for chronic HCV infection.
• Patient is able to avoid use of anticoagulants, nonsteroidal anti-inflammatory agents and aspirin for at least seven (7) days preceding the initial liver biopsy and continuing throughout the entire study.

Exclusion Criteria

• Patient is under the age of legal consent, is mentally or legally incapacitated
• Patient has a history of stroke, chronic seizures, or major neurological disorder.
• Patient did not achieve a viral response to prior treatment with licensed interferon-based therapy (i.e., is a *null responder*). Viral response is defined by a >=2-log10 decline in HCV viral RNA within the first 12 weeks of therapy.
• Patient has previously been treated with an NS3/4A protease inhibitor (investigational or licensed) for chronic HCV infection.
• Evidence of high grade bridging fibrosis (e.g., METAVIR score >3, Ishak score >4 or Scheuer score >3) from prior liver biopsy within 3 years of study entry and/or non biopsy procedure (e.g. Fibroscan) as per local guidelines.
• Patient has evidence or history of chronic hepatitis not caused by HCV infection including but not limited to non-HCV viral hepatitis, nonalcoholic steatohepatitis (NASH), drug-induced hepatitis or autoimmune hepatitis.
• Patient has clinical or laboratory evidence of cirrhosis or other advanced liver disease.
• Patient has a history of clinically significant uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
• Patient has a history of clinically significant neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified