Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin Versus Ribavirin Dose Reduction for the Management of Anemia

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 12.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C; MedDRA version: 9.1 Level: PT Classification code 10019744 Term: <Manually entered code. Term in E.1.1>; MedDRA version: 9.1 Level: SOC Classification code 10021881 Term: <Manually entered code. Term in E.1.1>; MedDRA version: 9.1 Level: SOC Classification code 10019805 Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2009-012782-63-FR
• Lead Sponsor: Schering-Plough Research Institution, A Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-17
• Study Completion: 2011-10-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 660

Inclusion Criteria

Inclusion Criteria for CHC
1. Subject must have previously documented CHC genotype 1 infection.
Subjects with other or mixed genotypes are not eligible. 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. Hemoglobin concentration at Screening must be =15 g/dL for both females
and males and will be strictly observed.
3. Subject must have a liver biopsy with histology consistent with CHC and no
other etiology. Copies of the pathology report and histology slides (suitable
for evaluation by the trial central pathologist) are required for the subject to be
included in the trial. The slides and the pathology report must be accessible
by the trial site prior to Day 1. Using the Scoring Systems for Hepatic Fibrosis, the investigator must determine the level of fibrosis demonstrated by the biopsy.
a. For subjects with fibrosis F0-3 the biopsy must have been obtained
within 3 years of the screening visit. If the timing of the liver biopsy
does not meet this criterion, the liver biopsy may be performed
between Screening and Day 1 (only if the subject’s Screening Visit
confirms that the subject meets the other trial inclusion criteria).
b. For subjects with F4 (cirrhosis), any historic liver biopsy demonstrating
cirrhosis will be accepted regardless of length of time since biopsy.
Two unstained slides are preferred for reading by the central pathologist
selected by the sponsor; 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). The
central pathologist reading will be used for analysis purposes only; Day 1
procedures will be performed based upon the local report.
4. Subjects with bridging fibrosis (F3) or cirrhosis (F4) 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).
5. Subject must be =18 years of age.
6. Subject’s weight must be =40 kg and =125 kg.
7. Subject and subject’s partner(s) must each agree to use acceptable methods
of contraception as specified 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.
8. Subjects must be willing to give written informed consent.
9. Subjects must be willing to attend frequent site visits for the duration of the
trial.
10. Subjects must not have any contraindications for the use of erythropoietin.
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

Exclusion Criteria

1. Coinfected with HIV or hepatitis B
2. Prior treatment for HCV; except herbal remedies, except those with hepatotoxicity. Herbal remedies must be discontinued, except silymarin
3. Any investigational drug within 30 days
4. Receiving any of the following medication within 2 weeks: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide,propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin,pimozide, triazolam, and orally administered midazolam.
5. Participation in other clinical trial within 30 days or intention to participate during this trial. Collection of additional blood, urine, or tissue samples beyond that specified, is prohibited (unless related to the subject’s medical care)
6. Decompensated liver disease including, clinical ascites, bleeding varices, or hepatic encephalopathy
7. Diabetic or hypertensive with significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other significant abnormality
8. Pre-existing psychiatric condition(s), including:
a. Moderate or severe depression.
b. Depression associated with:
i. Hospitalization
ii. Electroconvulsive therapy
iii. Prolonged absence from work or significant disruption of daily functions
c. Suicidal or homicidal ideation or attempt
d. Severe psychiatric disorders (not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania)
e. Lithium use
f. Antipsychotic drug use
9. Substance abuse of specified drugs within specified timeframes (not including time spent in detoxification, hospitalization, or incarceration):
a. Alcohol, IV drugs, inhalational (not marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year
b. Multi-drug abuse within 3 years
c. Receiving opiate agonist substitution therapy within 1 year (unless monitored in an opioid substitution maintenance program)
d. Marijuana use is excessive or interfering with daily function. Discontinue any recreational marijuana
10. Pre-existing medical condition that could interfere with participation/completion of the trial:
a. CNS trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or CSF leak. Prior brain hemorrhage or intracranial aneurysms b. Seizure disorder unless seizure was >10 years ago, a single isolated event, no medications prescribed, and a normal neurological examination is documented
c. Stroke or transient ischemic attack
d. Immunologically mediated disease, celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis, or symptomatic thyroid disorder
e. Chronic pulmonary disease
f. Significant cardiac abnormalities/dysfunction including uncontrolled hypertension or use of antianginal agents
g. Medical condition requiring chronic systemic cortico

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified