The Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants with Chronic Hepatitis C Infectio
- Conditions
- Chronic genotype 1 or genotype 4 Hepatitis C Virus infectionMedDRA version: 20.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-003006-16-SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 57
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 <800,000 IU/mL at the time of screening.
4. For participants with GT1a, no evidence of NS5A RASs detected at screening at positions 28, 30, 31, and/or 93.
5. The participant has liver disease staging assessment as follows:
a) Absence of cirrhosis (F0 to F3) defined as any one of the following:
i. Liver biopsy performed within 24 months of Day 1 showing absence of cirrhosis, or
ii. FibroScan® performed within 12 months of Day 1 with a result =12.5 kPa (only for participants aged 12 years up to 18 years), or
iii. In the absence of criterion i. or ii. above, absence of cirrhosis can be determined by the investigator according to local clinical standards that includes physical examination during screening in combination with laboratory evaluation during screening and/or imaging test within 6 months of screening.
b) Compensated Cirrhosis (F4) defined as any one of the following:
i. Liver biopsy performed prior to Day 1 showing cirrhosis, or
ii. FibroScan® performed within 12 months of Day 1 with a result >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 consistent with cirrhosis (such as firm or enlarged liver, splenomegaly).
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
b) 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,
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method