CHONIC HEPATITIS C MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Product Name: albinterferon alfa-2b
Product Code: ABF656A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: albuferom
Concentration unit: µg microgram(s)
Concentration type: equal
Conc
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Provide written informed consent in accordance with institutional and regulatory guidelines; willing and able to comply with study protocol procedures 2. Age of 18 years or older 3. Have a clinical diagnosis of chronic hepatitis C, including detectable HCV RNA at the time of screening 4. Are infected with HCV genotype 1 (1a, 1b or mixed subtypes 1a/1b) only; patients with mixed HCV genotypes (e.g., 1/2, 1/3, etc.) or other genotypes (e.g., 2, 3, etc.) will be excluded 5. Naïve to IFNα-based therapy 6. Have had a liver biopsy within 2 years prior to Screening visit 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: 1. Women of child-bearing potential (WOCBP), 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 4. History or evidence of decompensated liver disease (ascites, variceal bleeding, hepatic encephalopathy, or other signs of progressive portal hypertension or progressive hepatic insufficiency) 5. Nonalcoholic steatohepatitis (NASH) if ballooning degeneration or Mallory bodies are present on liver biopsy 6. Other forms of liver disease (e.g., alcoholic, autoimmune, biliary, or Wilson?s); Gilbert?s or Dubin-Johnson syndromes will not exclude patients 7. Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 8. History of moderate, severe or uncontrolled psychiatric disease (e.g., depression [including a history of hospitalization or prior suicidal attempt], bipolar disease, schizophrenia, or personality disorder). Patients with a history of mild, stable depression may be considered provided that a pretreatment assessment (including a Hospital Anxiety and Depression Scale [HADS] depression subscale [HADS-D] score of ≤ 8) of the patient?s affective status supports that the patient is clinically stable. Patients with a HADS-D score of > 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of up to four alb-IFN Q4w regimens (1500 μg, 1800 μg, 2100 μg and 2400 μg) plus daily RBV in IFNα-naïve patients with genotype 1 CHC.;Secondary Objective: To characterize the efficacy of up to four alb-IFN Q4w regimens (1500 μg, 1800 μg, 2100 μg and 2400 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 Week 72 or 24 weeks post-treatment for patients who discontinue treatment early Virologic Response below LOQ (43 IU/mL) at Week 12;Primary end point(s): To evaluate the safety and tolerability of up to four alb-IFN Q4w regimens (1500 μg, 1800 μg, 2100 μg and 2400 μg) plus daily RBV in IFNα-naïve patients with genotype 1 CHC. | — |
Countries
Italy
Outcome results
None listed