An open-label, randomized, multicenter, active-controlled,dose-ranging study to evaluate the safety and efficacy ofalbinterferon alfa-2b administered every 4 weeks plusribavirin in interferon alfa-naïve patients with genotype 1chronic hepatitis C - ND
- Conditions
- CHONIC HEPATITIS CMedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C
- Registration Number
- EUCTR2006-006803-35-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
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
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 <20 pg/mL], or
(2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy [in
the case of oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow-up hormone level assessment], or (3) agree to use one or more of the
below listed acceptable methods of contraception in addition to having a male partner who
correctly uses condoms or is sterile prior to the female patient?s entry into the study. Reliable
contraception should be maintained throughout the study and for 7 months after the last dose
of RBV.
Surgical sterilization (e.g., bilateral tubal ligation)
Hormonal contraception (implantable, patch, oral)
Copper coated intrauterine device (IUD) with a documented failure rate of less than 1%
per year
2. Fertile males, defined as all males physiologically capable of conceiving offspring may be
enrolled in this study if the patient agrees to use a condom and his female partner agrees to
use one or more of the acceptable methods of contraception listed above from the date of
screening until 7 months after their last dose of RBV
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG laboratory
test (> 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of up to four alb-IFN Q4w regimens (1500 μg, 1800 μg, 2100 μg<br>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<br>2400 μg) plus daily RBV as measured by:<br> Sustained Virologic Response (SVR), defined as undetectable HCV RNA (i.e., HCV RNA<br>< limit of detection [LOD]; 15 IU/mL) at Week 72 or 24 weeks post-treatment for patients who<br>discontinue treatment early<br> 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<br>and 2400 μg) plus daily RBV in IFNα-naïve patients with genotype 1 CHC.
- Secondary Outcome Measures
Name Time Method