A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1

Conditions: Chronic Hepatitis C
MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
MedDRA version: 9.1Level: PTClassification code 10019744Term: Hepatitis C
MedDRA version: 9.1Level: SOCClassification code 10021881Term: Infections and infestations
MedDRA version: 9.1Level: SOCClassification code 10019805Term: Hepatobiliary disorders

Registration Number: EUCTR2007-005508-42-NL

Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1080

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

Study Part Specific Exclusion Criteria:
-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 with the subject participating in and completing the study
-Subjects who are part of the site personnel directly involved with this study
-Subjects who are family members of the investigational study staff
-Subjects who had life-threatening serious adverse event (SAE) during screening period
Laboratory Exclusion Criteria
Note: If any of the laboratory exclusion criteria are met, then the site may have the subject retested for eligability as desribed in the protocol
-Hematological, biochemical, and serologic criteria (growth factors may not be used to achieve study entry requirements):
a. Hemoglobin <12 g/dL for females and <13 g

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 12/10/2019