Chronic genotype 1 or genotype 4 Hepatitis C Virus infection MedDRA version: 20.1 Level: LLT Classification code 10047457 Term: Viral hepatitis C System Organ Class: 100000004862
Conditions
Interventions
Trade Name: ZEPATIER
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELBASVIR
CAS Number: 1370468-36-2
Current Sponsor code: MK-8742
Other descriptive name: ELBASVIR, EBR
Concentration un
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant has HCV RNA (=1,000 IU/mL in peripheral blood) at the time of screening. 2. The participant has documented chronic HCV GT1 or GT4 infection as follows: a) positive for anti-HCV antibody, HCV RNA, or HCV GT1 or GT4 at least 6 months before Day 1; or b) positive for anti-HCV antibody or HCV RNA with a liver biopsy consistent with chronic HCV infection (such as the presence of fibrosis) before Day 1. 3. For participants with GT4, HCV RNA 12.5 kPa (only for participants aged 12 years up to 18 years), or iii. In the absence of criterion i. or ii. above, cirrhosis can be determined by the investigator according to local clinical standards that includes physical examination during screening in combination with historical or current laboratory evaluation and/or imaging with findings 6. The participant has an HCV treatment status that is one of the following: a) GT1 and GT4: HCV TN (defined as no prior exposure to any interferon [IFN]-containing regimen, RBV, or other HCV-specific DAA agent). b) GT1 only: HCV TE (defined as prior virologic failure during or after treatment with an IFN or pegylated-IFN with or without RBV; or intolerance to IFN or pegylated-IFN with or without RBV). Participants cannot have previously received treatment with HCV specific DAA agents. 7. The participant is male or female between 3 years to less than 18 years of age on day of signing informed consent/assent. 8. For participants in the Mini Age Cohorts only (these restrictions do not apply for the Expanded Age Cohorts): a) Weight: i. Age Cohort 1: =32 kg ii. Age Cohort 2: =19 kg iii. Age Cohort 3: =12 kg a) Race: Participants of non-Asian Race. 9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) as defined in the protocol OR b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment. 10. The participant’s legally acceptable representative(s) provides written informed consent for the study and, when applicable, the participant provides written informed assent. 11. The participant must be able to swallow the placebo to EBR/GZR (FDC) prior to allocation. This is applicable only to participants in Mini Age Cohort 1 and, if it is determined by PK analysis that Expanded Age Cohort 1 will also r
Exclusion criteria
Exclusion criteria: 1. The participant 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. 2. The participant is cirrhotic AND has a Child-Turcotte-Pugh score >6, corresponding to a Child Class B or C. 3. The participant is co-infected with HIV. 4. Has evidence of past or present hepatitis B infection (either hepatitis B core antibody [anti-HBc] positive and/or hepatitis B surface antigen [HBsAg] positive) at screening. 5. The participant has a history of malignancy =5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy including HCC. 6. A WOCBP is expecting to conceive or donate eggs from Day 1 through at least 14 days after the last dose of study treatment or longer if dictated by local regulations. 7. The participant has any of the following conditions: a) organ transplants (including hematopoietic stem cell transplants) other than cornea and hair. b) poor venous access that precludes routine peripheral blood sampling required for this study. c) history of gastric surgery (eg, stapling, bypass) or malabsorption disorders (eg, uncontrolled celiac sprue disease). d) any clinically significant cardiac abnormalities/dysfunction that may interfere with participant treatment, assessment, or compliance with the protocol, including but not limited to: unstable angina, unstable congestive heart failure, unstable arrhythmia; participants currently under evaluation for a potentially clinically significant cardiac abnormality/dysfunction are also excluded. e) any major medical condition, clinically significant illness (other than HCV), pre study laboratory or electrocardiogram (ECG) abnormality, or history of any illness, including failure to thrive, which, in the opinion of the investigator, might interfere with participant treatment, assessment, compliance with the protocol, or confound the results of the study or pose additional risk in administering the study drug to the participant. f) history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures. g) medical/surgical conditions that may result in a need for hospitalization during the study duration. h) any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor antagonists, or other immunosuppressant drugs through FW24. i) life-threatening serious adverse event (SAE) during the screening period. j) Evidence of history of chronic hepatitis not caused by HCV, including but not limited to, drug-induced hepatitis, hemochromatosis, Wilson’s disease, a1 antitrypsin deficiency, alcoholic liver disease, and autoimmune hepatitis. 8. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. 9. The participant is taking or plans to take any of the prohibited medications listed in the protocol or is taking herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum), from 2 weeksprior to Day 1 through 2 weeks after the study treatment period. 10. The participant ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the steadystate EBR and GZR PK in children and adolescents grouped by age.;Secondary Objective: 1. To evaluate the safety and tolerability of 12 weeks of treatment with EBR/GZR in children and adolescents grouped by age. 2. To evaluate the efficacy of 12 weeks of treatment with EBR/GZR in children and adolescents grouped by age, as assessed by the proportion of participants achieving SVR12. ;Primary end point(s): Week 4 AUC0-24, maximum observed drug concentration (Cmax), drug concentration immediately pre-dose (Ctrough), and apparent clearance (CL/F).).;Timepoint(s) of evaluation of this end point: Treatment Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 weeks after treatment completion;Secondary end point(s): 1. Number of participants experiencing AEs. 2. Number of participants discontinuing study drug due to AEs. 3. SVR12: defined as HCV RNA <lower limit of quantification (LLOQ) (either target detected, but unquantifiable [TD(u)] or target not detected [TND]) 12 weeks after the end of all study therapy. | — |
Countries
Germany, Poland, Sweden, United States
Contacts
Public ContactGCTO
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed