Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
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| ClinicalTrials.gov Identifier: NCT03379506 |
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Recruitment Status :
Recruiting
First Posted : December 20, 2017
Last Update Posted : February 7, 2019
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HCV Infection | Drug: EBR/GZR | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 56 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 25, 2018 |
| Estimated Primary Completion Date : | December 1, 2019 |
| Estimated Study Completion Date : | July 17, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: EBR/GZR
Ages 12 to less than 18 years will receive Fixed Dose Combination (FDC) EBR/GZR tablets once daily for 12 weeks; and ages 3 to less than 12 years will receive a pediatric formulation of EBR/GZR once daily for 12 weeks. There will be 24 weeks of follow-up.
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Drug: EBR/GZR
Ages 12 to less than 18 years will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily. Ages 3 to less than 12 years will receive oral granules pediatric formulation in a soft food vehicle once daily with EBR/GRZ not to exceed 50 mg/100 mg. |
Primary Outcome Measures :
- Area under the concentration-time curve of EBR [ Time Frame: Week 4: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hr ]Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) of plasma EBR
- Area under the concentration-time curve of GZR [ Time Frame: Week 4: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hr ]Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) of plasma GZR
- Maximum Concentration of EBR [ Time Frame: Week 4: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hr ]Maximum observed concentration (Cmax) of plasma EBR
- Maximum Concentration of GZR [ Time Frame: Week 4: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hr ]Maximum observed concentration (Cmax) of plasma GZR
- Clearance of EBR [ Time Frame: Week 4: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hr ]Apparent clearance (CL/F) of plasma EBR
- Clearance of GZR [ Time Frame: Week 4: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hr ]Apparent clearance (CL/F) of plasma GZR
- Pre-dose Concentration of EBR [ Time Frame: Week 4: Predose ]Pre-dose concentration (Ctrough) of plasma EBR
- Pre-dose Concentration of GZR [ Time Frame: Week 4: Predose ]Pre-dose concentration (Ctrough) of plasma GZR
Secondary Outcome Measures :
- Adverse Events (AEs) [ Time Frame: Up to 24 weeks ]Number of participants experiencing adverse events (AEs).
- Discontinuations due to an AE [ Time Frame: Up to 12 weeks ]Number of participants discontinuing study drug due to AEs.
- Sustained Virologic Response [ Time Frame: Week 24 ]Percentage of participants achieving sustained virologic response defined as HCV RNA <lower limit of quantification (LLOQ) 12 weeks after the end of all study therapy (SVR12).
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| Ages Eligible for Study: | 3 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379506
Contacts
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Locations
| United States, California | |
| University of California San Francisco ( Site 0020) | Recruiting |
| San Francisco, California, United States, 94158 | |
| Contact: Study Coordinator 415-476-1756 | |
| United States, Florida | |
| Florida Hospital ( Site 0006) | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Study Coordinator 407-303-7756 | |
| United States, Georgia | |
| Children's Center for Advanced Pediatrics ( Site 0204) | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: Study Coordinator 404-785-0421 | |
| United States, Massachusetts | |
| Children's Hospital Boston ( Site 0009) | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Study Coordinator 617-355-5837 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center ( Site 0003) | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Study Coordinator 513-636-7511 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh ( Site 0024) | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Study Coordinator 412-692-6444 | |
| United States, Texas | |
| American Research Corporation ( Site 0200) | Recruiting |
| San Antonio, Texas, United States, 78215 | |
| Contact: Study Coordinator 210-918-8851 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center ( Site 0017) | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Study Coordinator 206-987-4636 | |
| Germany | |
| Medizinische Hochschule Hannover Kinderklinik K10 ( Site 0105) | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: Study Coordinator +495115323208 | |
| Klinikum Starnberg ( Site 0107) | Recruiting |
| Starnberg, Germany, 82319 | |
| Contact: Study Coordinator +498151182330 | |
| Helios Klinikum Wuppertal GmbH ( Site 0104) | Recruiting |
| Wuppertal, Germany, 42283 | |
| Contact: Study Coordinator +492028963831 | |
| Poland | |
| WSOZ im.T.Browicza w Bydgoszczy ( Site 0800) | Recruiting |
| Bydgoszcz, Poland, 85-030 | |
| Contact: Study Coordinator +48602575396 | |
| Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 0810) | Recruiting |
| Lodz, Poland, 91-347 | |
| Contact: Study Coordinator +48601272443 | |
| MED-POLONIA Sp. z o.o. ( Site 0808) | Recruiting |
| Poznan, Poland, 60-693 | |
| Contact: Study Coordinator +48616561700 | |
| Sweden | |
| Karolinska Universitetssjukhuset Huddinge. ( Site 0062) | Recruiting |
| Stockholm, Sweden, 141 86 | |
| Contact: Study Coordinator +46858587321 | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT03379506 History of Changes |
| Other Study ID Numbers: |
5172-079 2015-003006-16 ( EudraCT Number ) MK-5172-079 ( Other Identifier: Merck Protocol Number ) |
| First Posted: | December 20, 2017 Key Record Dates |
| Last Update Posted: | February 7, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Hepatitis, Viral, Human Hepatitis Infection |
Communicable Diseases Virus Diseases Flaviviridae Infections RNA Virus Infections Liver Diseases Digestive System Diseases |