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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
525
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00759200