An open-label, randomized, multicenter, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa 2b administered every 4 weeks plus ribavirin in interferon alfa-naïve patients with genotype 2/3 chronic hepatitis C
- Conditions
- chronic hepatitis CMedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
- Registration Number
- EUCTR2008-002039-34-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
- 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 <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 at least two reliable forms of effective contraception during treatment and during the 7-month post-treatment follow-up period. One method is the male’s use of a condom with spermicide. The other must be one of the following:
• Surgical sterilization (e.g., bilateral tubal ligation)
• Hormonal contraceptives include any marketed contraceptive agent that includes an
estrogen and/or a progestational agent
• Intrauterine device (copper or hormonal)
• Diaphragm with spermicide
• Sponge
- 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 with spermicide 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
- 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
- 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 < 3.5 g/dl])
- Other forms of liver disease (e.g., alcoholic, autoimmune, biliary, or Wilson’s). However, Gilbert’s or Dubin-Johnson syndromes will not exclude patients.
- Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- 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 revi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method