Status:
COMPLETED
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1....
Detailed Description
PegIntron Dose will be administered once weekly subcutaneously on the same day of the week: Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid \[HCV RNA\] quantitative polymerase chain reaction \[qPCR\] plasma positive)
- Individuals with HCV genotype 1 (mixed 1a/1b is acceptable)
- Compensated liver disease
- Pretreatment liver biopsy slides available
- Adults aged 18-70
- Individuals weighing 88-275 pounds (40-125 kg)
- Free from substance abuse for past 2 years
- Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given)
- Patients and partners of patients willing to use adequate contraception during the course of the study
- Hematology laboratory results of:
- Hemoglobin (HGB) ≥ 12 g/dL for females or ≥ 13g/dL for males
- White Blood Cell Count (WBC) ≥ 3,000/mm\^3
- Neutrophils ≥ 1,500/mm\^3
- Platelets ≥ 80,000/mm\^3
- Chemistry laboratory results of:
- Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin
- Antinuclear antibody (ANA) ≤ 1:320
- Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, glycosylated hemoglobin \[HbA1C\] must be ≤ 8.5%
- EXCLUSION CRITERIA:
- Previous hepatitis C treatment
- Pregnant women or partners of pregnant women
- Patients or partners of patients who intend to become pregnant any time during the 48 weeks
- Women who are breastfeeding
- Individuals with liver disease not caused by hepatitis C
- Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
- Patients with a history of liver cancer (hepatocellular carcinoma)
- Known blood disorders such as hemoglobinopathy, coagulopathy, or glucose-6-phosphate dehydrogenase \[G6PD\] deficiency
- Body organ transplant
- Any known or suspected cancer within the past 5 years
- Individuals who currently use epoetin \[EPO\], granulocyte colony stimulating factor \[G-CSF\] and/or granulocyte monocyte colony stimulating factor \[GM-CSF\]
- Those having a history of or active clinical gout
- Individuals who have chronic pulmonary disease
- Individuals who have a medical condition that would likely require systemic steroids
- Those with a history of central nervous system (CNS trauma) or seizure disorders
- Current or previous use of lithium or antipsychotic drugs
- Individuals who currently have or show signs of moderate to severe depression or history of significant psychiatric disorders
- Patients with clinically significant electrocardiogram (ECG) abnormalities
- Individuals with serious heart problems such as those who have had a heart attack, uncontrolled high blood pressure, or other heart problems
- Patients that weigh \> 231-275 pounds (105-125 kg) AND have a body mass index (BMI) \> 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age \< 55 for male relatives or \< 65 for female relatives (b) Individuals with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
4469 Patients enrolled
Trial Details
Trial ID
NCT00081770
Start Date
March 1 2004
End Date
November 1 2007
Last Update
April 4 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.