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

• Conditions: Hepatitis C; MedDRA version: 17.0Level: LLTClassification code 10019183Term: HCVSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001345-32-SE
• Lead Sponsor: Schering Corporation, a Subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-21
• Last Update Posted: 10 July 2015

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 infection 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 without the evidence of cirrhosis and hepatocellular carcinoma.
7. 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).
If the prior liver biopsy was obtained outside the acceptable windows, a repeat biopsy may be performed, and the results must show no evidence of cirrhosis and hepatocellular carcinoma in order for the subject to be randomized in the study.
For countries where liver biopsy is not performed prior to treatment and where noninvasive tests (for e.g. FibroScan and/or FibroTest) are used for staging of liver disease, these results may be used to assess eligibility. Subjects with a documented FibroScan score of =9.5 kPa, or FibroTest score of =0.58 are allowed to be enrolled in the study. These non-invasive tests done prior to screening are acceptable if they were performed within 1 year of screening and meet the indicated cut-offs. If the prior non-invasive tests were not performed within 1 year of screening, results from one of these non-invasive tests is required before study drug dosing. If a subject has both liver biopsy and one of
these non-invasive tests, whichever test demonstrates the presence of cirrhosis would be used to determine eligibility. In other words, if the liver biopsy shows cirrhosis, the subject is excluded, regardless of results of the non-invasive assay. If the liver biopsy does not show cirrhosis, but the non-invasive assay
does, then the subject is still excluded.
8. Subject has had an ECG within 6 months prior to the screening visit (or between the screening visit and Day 1).
9. Subject and subject’s partner(s) must each agree to use acceptable methods of contraception as specified in the protocol Section 7.6.1 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. Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period. Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed
consent to provide information regarding any pregnancy.
For the purposes of this protocol, a male subject who is not of reproductive potential is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as: one who has undergone a successful vasectomy. A successful vasectomy is defined as: (1) microscopic
documentation of azoospermia, or (2) a vasectomy more than 2 yea

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