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 C; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2008-002039-34-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 525

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

- 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])
- 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified