Chronic Hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C MedDRA version: 9.1 Level: PT Classification code 10019744 Term: Hepatitis C MedDRA version: 9.1 Level: SOC Classification code 10021881 Term: Infections and infestations MedDRA ver
Conditions
Sponsors
Schering-Plough Research Institute, a Division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and Criteria for Inclusion: Adult subjects with CHC HCV genotype 1 and with no previous treatment for CHC will be selected for the study. The subject must meet ALL criteria listed below for entry: Inclusion Criteria for CHC: 1. Subject must have documented CHC genotype 1 infection. The HCV-RNA result obtained from the central laboratory at the screening visit must confirm genotype 1 infection and be =10,000 IU/mL. 2. Subject must have a liver biopsy with histology consistent with CHC and no other etiology. Copies of the pathology report and histology slides are required for the subject to be included in the study. The slides and the pathology report must be available at the study site prior to subject randomization. Two unstained slides are preferred; however, one slide stained with hematoxylin plus eosin (H & E) plus one slide stained with Masson’s trichrome will be accepted (slides should be reviewed by the investigator to confirm adequacy). a. No cirrhosis: Biopsy must be within 3 years of the Screening visit. For biopsies performed more than 18 months prior to the Screening visit, fibrosis marker testing will be performed to assess level of fibrosis b. Cirrhosis: Any historic liver biopsy demonstrating cirrhosis will be sufficient regardless of length of time since biopsy. c. Subjects whose timing of liver biopsy does not meet the criteria for subject eligibility may have a liver biopsy performed between Screening visit and Day 1 after the Screening evaluation confirms that the subject meets the study inclusion criteria 3. Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC). General Inclusion Criteria: 4. Subject must be 18 years old or older. 5. Subject must weigh between 40 kg and 125 kg. 6. Subject and subject’s partner(s) must each agree to use acceptable methods of contraception as specified in 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 drug, or longer if dictated by local regulations. 7. Subjects must be willing to give written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Study Part Specific Exclusion Criteria: A. Black/African American subjects are excluded from Part I of this study. B. Non-black/African American subjects are excluded from Part II of this study. -Subjects known to be co-infected with HIV or hepatitis B virus (HBsAg positive), or infected with hepatitis HCV genotypes other than genotype 1 (including mixed genotypes) -Subjects who received prior treatment for hepatitis C; other than herbal remedies, except those with known hepatotoxicity (which are exclusionary). All herbal remedies used for hepatitis C treatment must be discontinued before Day 1. Only silymarin (milk thistle) is allowed during the study -Treatment with any investigational drug within 30 days of the randomization visit in this study -Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study -Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy -Diabetic and hypertensive subjects with clinically significant ocular examination findings as defined in the protocol -Pre-existing psychiatric condition(s), as defined in protocol -Clinical diagnosis of substance abuse as defined in the protocol by drug type and timeframe -As further defined in the protocol, any known pre-existing medical condition that could interfere with the subject’s participation in and completion of the study including but not limited to: a. Central nervous system (CNS) trauma b. Current or history of seizure disorder c. History of stroke or transient ischemic attack d. Immunologically-mediated disease e. Chronic pulmonary disease f. Current or history of any clinically significant cardiac abnormalities/dysfunction g. Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the study h. Active clinical gout within the last year i. Hemoglobinopathy j. Myelodysplastic syndromes k. Coagulopathy l. Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair m. Poor venous access that precludes routine peripheral blood sampling required for this study n. Subjects with indwelling venous catheters o. Subjects with a history of gastric surgery (eg, stapling, bypass) or subjects with a history of malabsorption disorders (eg, celiac sprue disease) -Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible -Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the study period. Male subjects with partners who are, or intend to become, pregnant during the study period -Any other condition which, in the opinion of a physician, would make the subject unsuitable for enrollment or could interfere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of two therapeutic regimens of boceprevir dosed 800 mg three times a day (TID) orally (PO) (hereafter called boceprevir) in combination with PegIntron 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (600 mg/day to 1400 mg/day) PO (hereafter called PEG + RBV [WBD]) to therapy with PEG + RBV [WBD] alone in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 1.; Secondary Objective: The secondary objectives of both parts of this study are: • To evaluate the safety of boceprevir when used in combination with PEG + RBV (WBD). • To define predictors of sustained virologic response (SVR) such as epidemiologic factors, disease characteristics and on-treatment response. • To develop the relationship between steady state pharmacokinetic parameters, obtained from population based pharmacokinetic model and responses in a subset of subjects. ; Primary end point(s): The primary efficacy endpoint is the achievement of sustained virologic response (SVR) defined as undetectable plasma HCV-RNA at FW 24. Subjects will be declared treatment failures in one of the following ways: • Subjects in any treatment arm who have detectable HCV-RNA at FW 24. • Subjects in any treatment arm who have detectable HCV-RNA at TW 24. • Subjects in any treatment arm who are missing their HCV-RNA at FW 24 with detectable HCV-RNA at FW 12. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed