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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002039-34-DE
• Date of registration: 22/09/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 15/12/2008
• Target sample size: 525
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002039-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

France, Germany, Greece, Italy, Poland, Spain, United Kingdom

Key inclusion & exclusion 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:
- 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

chronic hepatitis C
MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C

Intervention(s)

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)
Concentration type: equal
Concentration number: 180-

Product Name: albinterferon alfa-2b
Product Code: ABF656
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: albumin interferon alfa-2b
CAS Number: 472960-22-8
Current Sponsor code: ABF656
Other descriptive name: Albuferon
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.4-

Trade Name: Ribasphere
Product Name: Ribasphere
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ribavirin
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

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.

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.

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)

Secondary ID(s)

CABF656B2202