Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Timothy Morgan, MD
With
Vertex Pharmaceuticals Incorporated
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic Hepatitis C genotype 1 infection
Treatment naïve
Age \>18 years
Agree to genetic testing
You may not be if
Liver disease other than from hepatitis C
HCV infection with mixed genotypes
Decompensated liver disease
AFP\>100ng/ml.
Known HIV infection
Serum 25(OH)D less than 12ng/ml or greater than 30ng/ml
Regular vitamin D supplement use
Regular calcium supplement use
Refusal to abstain from vitamin D supplementation
Current or past history of kidney stones
Current use of any of the prohibited medications listed in section 5.5 and the INCIVEK® package insert.
Need for therapeutic vitamin D or calcium (e.g. treatment for osteoporosis, osteomalacia, hyperparathyroidism etc.), in the opinion of the investigator
Significant substance abuse within the past 6 months,
Suicidal attempt in the past 10 years or suicidal ideation in past 3 months, or any other psychiatric condition that the investigator deems would make a subject unsuited for treatment with peginterferon or ribavirin.
Confirmed or suspected malignancy, or history of malignancy within the past 3 years (except treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
Any autoimmune disease not easily controlled (in the opinion of the investigator)
Any condition resulting in malabsorption (
Poorly controlled thyroid disorder, or diabetes mellitus (HbA1c \> 9)
Glomerular diseases (e.g., glomerulosclerosis or glomerulonephritis) associated with a serum creatinine \>1.5 times the upper limit of normal
Current or history of any clinically significant cardiac abnormalities/dysfunction (eg, angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension or history of use of antianginal agents for cardiac conditions (Inclusion will be considered if clearance by a cardiologist is obtained.)
Receipt of an investigational drug within the past 30 days
Females who have a positive pregnancy test at the time of screening, are breastfeeding or who anticipate pregnancy within the next 18 months, or men with pregnant partners
Lack of agreement from subject to use two forms of acceptable contraception
History or other evidence of any significant illness which, in the opinion of the investigator, would make the patient, unsuitable for the study
Laboratory Exclusions
Hemoglobin: \<12gm/dl male or female
Neutrophil: \<1,200/mm3
Platelets: \<90,000/mm3
INR: \>1.5
Albumin: \<3.2gm/dl
Total Bilirubin: \>2.0mg/dl
HbA1c: \>9.5%
Serum Creatinine: \>1.5 times the upper limit of normal
Serum Calcium Within local laboratory normal range
