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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00759200




Registration number
NCT00759200
Ethics application status
Date submitted
23/09/2008
Date registered
25/09/2008
Date last updated
16/11/2016

Titles & IDs
Public title
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
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
Secondary ID [1] 0 0
CABF656B2202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - alb-interferon alfa 2b
Treatment: Drugs - alb-interferon alfa 2b
Treatment: Drugs - alb-interferon alfa 2b
Treatment: Drugs - alb-interferon alfa 2b
Treatment: Drugs - peg-interferon

Experimental: alb-interferon arm 1 -

Experimental: alb-interferon arm 2 -

Experimental: alb-interferon arm 3 -

Experimental: alb-interferon arm 4 -

Active Comparator: peg-interferon -


Treatment: Drugs: alb-interferon alfa 2b
900 mcg every 4 weeks

Treatment: Drugs: alb-interferon alfa 2b
1200 mcg every 4 weeks

Treatment: Drugs: alb-interferon alfa 2b
1500 mcg every 4 weeks

Treatment: Drugs: alb-interferon alfa 2b
1800 mcg every 4 weeks

Treatment: Drugs: peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
at every visit
Secondary outcome [1] 0 0
Viral load
Timepoint [1] 0 0
at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.

Eligibility
Key inclusion criteria
- Age of 18 years or older

- Clinical diagnosis of chronic hepatitis C

- Infection with HCV genotype 2 or 3

- No previous IFNa-based therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women of child-bearing potential if not using double barrier method of contraception,
pregnant or nursing

- Fertile males, unless condom with spermicide is used and female partner agrees to use
one or more of the acceptable methods until 7 months after last dose of RBV

- History or current evidence of decompensated liver disease; other forms of liver
disease

- Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

- History of moderate, severe or uncontrolled psychiatric disease

- History of seizure disorder

- History or clinical evidence of chronic cardiac disease, preexisting interstitial lung
disease or severe lung disease

- Clinically significant findings on eye/retinal examination

- History of immunologically mediated disease

- Organ transplantation other than cornea or hair transplant

- History of clinically significant hemoglobinopathy

- Diagnosis of malignancy of any organ system with the exception of localized basal cell
carcinoma of the skin

- History of galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption

- History of hypersensitivity to any of the study drugs or to drugs with similar
chemical structures

- Drug or alcohol addiction within the last 6 months and/or positive drug screening
tests

- Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14
days prior to Baseline visit

- Received concomitant systemic antibiotics, antifungals or antivirals for the treatment
of active infection within 14 days prior to Baseline visit.

- Received herbal therapies (including milk thistle or glycyrrhizin) or an
investigational drug within 35 days prior to Baseline visit

- Have a clinically significant laboratory abnormality

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative site - Clayton
Recruitment hospital [2] 0 0
Novartis Investigative site - Fitzroy
Recruitment hospital [3] 0 0
Novartis Investigative site - Greenslopes
Recruitment hospital [4] 0 0
Novartis Investigative site - Kingswood
Recruitment hospital [5] 0 0
Novartis Investigative site - Melbourne
Recruitment hospital [6] 0 0
Novartis Investigative site - Westmead
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Greenslopes
Recruitment postcode(s) [4] 0 0
- Kingswood
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Calgary
Country [2] 0 0
Canada
State/province [2] 0 0
Downsview
Country [3] 0 0
Canada
State/province [3] 0 0
Montreal
Country [4] 0 0
Canada
State/province [4] 0 0
Toronto
Country [5] 0 0
Canada
State/province [5] 0 0
Vancouver
Country [6] 0 0
France
State/province [6] 0 0
Cretail
Country [7] 0 0
France
State/province [7] 0 0
Nice
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Villejuif
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Düsseldorf
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Freiburg
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Köln
Country [16] 0 0
Greece
State/province [16] 0 0
Heraklion
Country [17] 0 0
Greece
State/province [17] 0 0
Loannina
Country [18] 0 0
Greece
State/province [18] 0 0
Patra-Rio
Country [19] 0 0
Greece
State/province [19] 0 0
Piraeurs
Country [20] 0 0
Greece
State/province [20] 0 0
Thessaloniki
Country [21] 0 0
India
State/province [21] 0 0
Chandigarh
Country [22] 0 0
India
State/province [22] 0 0
Hyderabad
Country [23] 0 0
India
State/province [23] 0 0
Lucknow
Country [24] 0 0
India
State/province [24] 0 0
Ludhiana
Country [25] 0 0
India
State/province [25] 0 0
Mumbai
Country [26] 0 0
India
State/province [26] 0 0
New Delhi
Country [27] 0 0
Italy
State/province [27] 0 0
Bologna
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Napoli
Country [30] 0 0
Italy
State/province [30] 0 0
Pavia
Country [31] 0 0
Italy
State/province [31] 0 0
Pisa
Country [32] 0 0
Italy
State/province [32] 0 0
Polermo
Country [33] 0 0
Italy
State/province [33] 0 0
Torino
Country [34] 0 0
Poland
State/province [34] 0 0
Bialystok
Country [35] 0 0
Poland
State/province [35] 0 0
Lodz
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Malaga
Country [39] 0 0
Spain
State/province [39] 0 0
Oviedo
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Taiwan
State/province [42] 0 0
Kaohsiung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
Thailand
State/province [45] 0 0
Bangkok
Country [46] 0 0
Thailand
State/province [46] 0 0
Chaingmai
Country [47] 0 0
Thailand
State/province [47] 0 0
Hat Yai
Country [48] 0 0
Thailand
State/province [48] 0 0
Muang
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Human Genome Sciences Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2
or 3 chronic hepatitis
Trial website
https://clinicaltrials.gov/show/NCT00759200
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications