chronic hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: peginterferon alfa-2a
CAS Number: 198153-51-4
Concentration unit: µg microgram(s)
Concentrati
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of 18 years or older 2. Clinical diagnosis of chronic hepatitis C, including detectable HCV RNA at the time of screening 3. Infection with HCV genotype 2 or 3. Subjects infected with mixed HCV genotypes (eg., genotype 1/2, 1/3, 2/3 etc.) at screening will not be enrolled into the study. Subjects with mixed genotype 2a/2b or 3a/3b may be enrolled. 4. No previous IFNa-based therapy 5. Ability to provide written informed consent in accordance with institutional and regulatory guidelines; willing and able to comply with study protocol procedures 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
Exclusion criteria: - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: and estradiol 5 mIU/mL). Men whose female partners are pregnant or contemplating pregnancy - History or current evidence of decompensated liver disease (ascites, variceal bleeding, hepatic encephalopathy, or other signs of progressive portal hypertension or progressive hepatic insufficiency [prothrombin INR > 1.4; serum albumin 8 will require further clinical evaluation for depression prior to inclusion into the study. The investigator must formulate and document a depression management plan prior to randomization for these patients, and must review the patient’s affective status according to the plan at every visit. Patients with a HADS anxiety subscale (HADS-A) score of > 8 may be enrolled at the investigator’s discretion. - History of seizure disorder - History or clinical evidence of chronic cardiac disease; ECG with clinically significant abnormality. The Long QT syndrome or QTc >450 msec for males and > 470 msec for females at screening or baseline. - Clinical evidence of pre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of up to four doses of alb-IFN Q4w (900 µg, 1200 µg, 1500 µg and possibly 1800 µg) plus daily RBV in IFNa naïve patients with genotype 2/3 CHC.;Secondary Objective: To characterize the efficacy of up to four 4 doses of alb-IFN Q4w (900 µg, 1200 µg,1500 µg and 1800 µg) plus daily RBV as measured by: • Sustained Virologic Response (SVR), defined as undetectable HCV RNA (i.e., HCV RNA < limit of detection [LOD]; 15 IU/mL) at 24 weeks post-treatment. • Virologic Response below LOQ (43 IU/mL) at Treatment Week 12 (TW12). • Rapid Virologic Response at Treatment Week 4 (RVR4), defined as HCV RNA < limit of quantification (LOQ [43 IU/mL]) • Early Virologic Response at Treatment Week 12 (EVR12), defined as a = 2 log10 reduction or HCV RNA < LOQ (43 IU/mL) • End of Treatment Response (ETR), defined as undetectable HCV RNA (< LOD [15 IU/mL]) at Week 24 or the visit closest to the date of last dose of either interferon or RBV within ±27 days of window • Change from baseline in log10 HCV RNA at Weeks 4, and 12 • Time to HCV RNA < LOD (15 IU/mL) ;Primary end point(s): The primary objective is to evaluate the safety and tolerability of alb-IFN Q4w regimens plus daily RBV in IFNa naïve patients with genotype 2/3 CHC. | — |
Countries
France, Germany, Greece, Italy, Poland, Spain, United Kingdom
Outcome results
None listed