Study of Boceprevir/Peginterferon Alfa-2a/ribavirin in Chronic Hepatitis C Subjects

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1250

Inclusion Criteria

1.Each subject must be willing and able to provide written informed consent for the trial.
2.Each subject must be ? 18years of age.
3.Each subject’s weight must be = 40 kg and = 125 kg
4.Subject must have previously documented CHC genotype 1 where genotyping is performed as standard of care. If genotyping is not considered standard of care, then determination can be done at screening. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the Screening Visit must confirm HCV genotype 1 infection with HCV RNA ?10,000 IU/mL
5.Subjects must have IL28b CC allele gene (with SNP rs12979860)
6.Subject has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma. A liver biopsy done prior to screening is acceptable if:
?Within 3 years of screening and the result was METAVIR (or equivalent) Stage 0 (F0) to 2 (F2).
?Within 1 year of screening and the result was Stage 3 (F3).
7.Subject and subject’s partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

1.Subject is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
2.Subjects co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive).
3.Subjects who were previously treated with an interferon and ribavirin regimen or HCV direct acting anti-viral regimen.
4.Prior attempt to treat hepatitis C with any investigational medication or herbal product.
5.Subjects receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events such as orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine). The following medications are also exclusionary if taken within 2 weeks prior to the Day 1 visit: alfuzosin, cisapride, triazolam, sildenafil, and tadalafil (the latter 2 only if they are used for the indication of chronic obstructive pulmonary disease (COPD).
6.Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial
7.Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
8.Subject has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
9.Subject is diabetic and/or hypertensive with clinically significant ocular examination findings within 6 months prior to the screening visit or between the screening visit and Day 1: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality.
10.Subject has pre-existing psychiatric conditions
11.Subject has a clinical diagnosis of substance abuse.
12.Subject has any known medical condition that could interfere with the subject’s participation in and completion of the trial
13.Subject has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years. Subjects under evaluation for malignancy are not eligible.
14.Female subject is pregnant, lactating, expecting to conceive or donate eggs OR Male subject is planning to impregnate or provide sperm donation or has a female sexual partner who is pregnant or is of childbearing potential and is unwilling to commit to using two methods of birth control throughout treatment and after the completion of all treatment
15.Subject is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
16.Subject has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. Note: Subjects with history of acute non-HCV-related hepatitis, which resolved > 6 months before study entry, can be enrolled.
17.Hemoglobin <12 g/dL for females and <13 g/dL for males;
18.Neutrophils <1500/mm3, or <1,200/mm3

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

Updated 6/30/2019