Phase 3
Completed N=3,070
Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00081770 ↗
Enrolled (actual)
3,070
Serious AEs
9.9%
Results posted
Oct 2009
Primary outcomePrimary: Sustained Virologic Response (SVR) Rate — 39.8; 38.0; 40.9 Percentage of participants — p=0.567
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 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR) Rate |
39.8; 38.0; 40.9 | 0.567 |
| SECONDARY Mean Change From Baseline in the Log Viral Load at Treatment Week 4 |
-2.32; -2.02; -2.45 | — |
| SECONDARY Virologic Response Rate at Treatment Week 12 |
39.9; 36.0; 45.0 | — |
| SECONDARY Mean Change From Baseline in the Log Viral Load at Treatment Week 2 |
-1.55; -1.30; -1.60 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00081770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.