Summary

for people ages 3-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Philip Rosenthal

Description

Summary

The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of MK-5172, a fixed dose combination (FDC) of elbasvir (EBR) and grazoprevir (GZR) in pediatric hepatitis C virus (HCV)-infected participants aged 3 years up to 18 years.

Official Title

A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to Less Than 18 Years With Chronic Hepatitis C Infection

Keywords

HCV Infection Infection Communicable Diseases Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic EBR/GZR

Eligibility

You can join if…

Open to people ages 3-17

  • Has documented chronic HCV genotype (GT)1 or GT4 infection
  • Has the following liver disease staging assessment: Absence of cirrhosis; Compensated cirrhosis
  • Has one of the following HCV treatment status: GT1 and GT4: HCV Treatment-naïve (TN)(defined as no prior exposure to any interferon [IFN]-containing regimen, ribavirin[RBV], or other HCV-specific direct acting antiviral (DAA) agent. GT1 only: HCV treatment-experienced (TE). Participants cannot have previously received treatment with HCV specific DAA agents.
  • Female is not pregnant, not breastfeeding, and is either not of childbearing potential or follows the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment.
  • A legally acceptable representative(s) provides written informed consent for the study and, when applicable, the participant provides written informed assent.

You CAN'T join if...

  • 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 cirrhotic AND has a Child-Turcotte-Pugh score >6, corresponding to a Child Class B or C.
  • Is co-infected with Human Immunodeficiency Virus (HIV).
  • Has evidence of past or present hepatitis B infection.
  • Has a history of malignancy ≤5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy.
  • Female expects to conceive or donate eggs from Day 1 through at least 14 days after the last dose of study treatment or longer.
  • Has any of the following conditions: organ transplants other than cornea and hair;poor venous access; history of gastric surgery or malabsorption disorders; any clinically significant cardiac abnormalities/dysfunction that may interfere with participant treatment, assessment, or compliance; any major medical condition which might interfere with participant treatment, assessment, or compliance; history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment; medical/surgical conditions that may result in a need for hospitalization during the study duration; any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor antagonists, or immunosuppressant drugs; life-threatening serious adverse event (SAE)during the screening period; history of chronic hepatitis not caused by HCV.
  • Female has a positive urine pregnancy test within 24 hours before the first dose of study treatment.
  • Is taking or plans to take prohibited medications, or is taking herbal supplements.
  • Has had previous HCV direct acting antiviral (DAA) treatment.
  • Is currently participating or has participated in a study with an investigational compound within prior 30 days
  • Has significant emotional problems or a clinically significant psychiatric disorder that may interfere with participant treatment, assessment, or compliance with the protocol.
  • Has clinically relevant drug or alcohol abuse within prior 12 months that may interfere with participant treatment, assessment, or compliance.

Locations

  • University of California San Francisco ( Site 0020) accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital and Medical Center, [Seattle, WA] ( Site 0017) accepting new patients
    Seattle Washington 98105 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT03379506
Phase
Phase 2
Study Type
Interventional
Last Updated