Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00402428




Registration number
NCT00402428
Ethics application status
Date submitted
20/11/2006
Date registered
22/11/2006
Date last updated
8/08/2013

Titles & IDs
Public title
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients
Scientific title
Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1
Secondary ID [1] 0 0
ACHIEVE-1
Secondary ID [2] 0 0
HGS1008-C1060
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 - albumin interferon alfa-2b
Treatment: Drugs - peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Active comparator: 1 - 180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day

Experimental: 2 - 900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day

Experimental: 3 - 1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day


Treatment: Drugs: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks

Treatment: Drugs: peginterferon alfa-2a
180 mcg once a week for 48 weeks

Treatment: Drugs: Ribavirin
1000 mg/day(for subjects \<75kg) or 1200 mg/day (for subjects

=,\> 75kg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sustained virologic response (SVR)
Timepoint [1] 0 0
Week 72
Secondary outcome [1] 0 0
Rapid virologic response
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Early virologic response
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Undetectable HCV RNA
Timepoint [3] 0 0
Week 24 and Week 48
Secondary outcome [4] 0 0
Normalization of ALT (a liver enzyme)
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Quality of life evaluation
Timepoint [5] 0 0
throughout the entire study
Secondary outcome [6] 0 0
Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing)
Timepoint [6] 0 0
Throughout the entire study

Eligibility
Key inclusion criteria
Key

* Diagnosis of chronic hepatitis C.
* Liver biopsy performed within 2 years of Day 0 or during screening.
* Infected with hepatitis C virus genotype 1.
* Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
* Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
* Have compensated liver disease.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
* History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
* Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
* Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
* A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
* Active seizure disorder within the last 2 years.
* Organ transplant other than cornea and hair transplant.
* Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
* Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
* Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
* Received any experimental agent within 28 days prior to Day 0.

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 3
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
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
1331
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
St George Hospital Clinical School of Medicine University of New South Wales - Kogarah
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [9] 0 0
St Vincent's Hospital - Fitzroy, Victoria
Recruitment hospital [10] 0 0
Western Hospital - Footscray
Recruitment hospital [11] 0 0
Austin Hospital - Heidelburg
Recruitment hospital [12] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [13] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [14] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [15] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [16] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2305 - New Lambton
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy, Victoria
Recruitment postcode(s) [10] 0 0
3011 - Footscray
Recruitment postcode(s) [11] 0 0
3081 - Heidelburg
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6160 - Fremantle
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Austria
State/province [30] 0 0
Graz
Country [31] 0 0
Austria
State/province [31] 0 0
Innsbruck
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
Nova Scotia
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Brno
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Hradec Kralove
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Melnik
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Opava
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Praha 2
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Praha 4
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Usti nad Labem
Country [46] 0 0
France
State/province [46] 0 0
Clichy
Country [47] 0 0
France
State/province [47] 0 0
Creteil
Country [48] 0 0
France
State/province [48] 0 0
Lyon Cedex 02
Country [49] 0 0
France
State/province [49] 0 0
Marseille Cedex 08
Country [50] 0 0
France
State/province [50] 0 0
Orleans
Country [51] 0 0
France
State/province [51] 0 0
Paris
Country [52] 0 0
France
State/province [52] 0 0
Pessac cedex
Country [53] 0 0
France
State/province [53] 0 0
Toulouse Cedex
Country [54] 0 0
France
State/province [54] 0 0
Vandoeuvre
Country [55] 0 0
Germany
State/province [55] 0 0
Berlin
Country [56] 0 0
Germany
State/province [56] 0 0
Duesseldorf
Country [57] 0 0
Germany
State/province [57] 0 0
Düsseldorf
Country [58] 0 0
Germany
State/province [58] 0 0
Essen
Country [59] 0 0
Germany
State/province [59] 0 0
Frankfurt / Main
Country [60] 0 0
Germany
State/province [60] 0 0
Freiburg
Country [61] 0 0
Germany
State/province [61] 0 0
Hannover
Country [62] 0 0
Germany
State/province [62] 0 0
Heidelberg
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Germany
State/province [65] 0 0
Marl
Country [66] 0 0
India
State/province [66] 0 0
Ludhiana
Country [67] 0 0
India
State/province [67] 0 0
Mumbai
Country [68] 0 0
India
State/province [68] 0 0
New Delhi
Country [69] 0 0
Israel
State/province [69] 0 0
Haifa
Country [70] 0 0
Israel
State/province [70] 0 0
Jerusalem
Country [71] 0 0
Israel
State/province [71] 0 0
Nazareth
Country [72] 0 0
Israel
State/province [72] 0 0
Petach Tikva
Country [73] 0 0
Israel
State/province [73] 0 0
Tel Aviv
Country [74] 0 0
Italy
State/province [74] 0 0
Bologna
Country [75] 0 0
Italy
State/province [75] 0 0
Milano
Country [76] 0 0
Italy
State/province [76] 0 0
Napoli
Country [77] 0 0
Italy
State/province [77] 0 0
Palermo
Country [78] 0 0
Italy
State/province [78] 0 0
Pavia
Country [79] 0 0
Italy
State/province [79] 0 0
San Giovanni Rotondo (FG)
Country [80] 0 0
Italy
State/province [80] 0 0
Torino
Country [81] 0 0
Poland
State/province [81] 0 0
Bialystok
Country [82] 0 0
Poland
State/province [82] 0 0
Chorzow
Country [83] 0 0
Poland
State/province [83] 0 0
Kielce
Country [84] 0 0
Poland
State/province [84] 0 0
Kraków
Country [85] 0 0
Poland
State/province [85] 0 0
Warszawa
Country [86] 0 0
Poland
State/province [86] 0 0
Wroclaw
Country [87] 0 0
Poland
State/province [87] 0 0
Lódz
Country [88] 0 0
Puerto Rico
State/province [88] 0 0
Santurce
Country [89] 0 0
Romania
State/province [89] 0 0
Bucharest
Country [90] 0 0
Romania
State/province [90] 0 0
Cluj-Napoca
Country [91] 0 0
Romania
State/province [91] 0 0
Lasi
Country [92] 0 0
Spain
State/province [92] 0 0
Badalona - Barcelona
Country [93] 0 0
Spain
State/province [93] 0 0
Barcelona
Country [94] 0 0
Spain
State/province [94] 0 0
Madrid
Country [95] 0 0
Spain
State/province [95] 0 0
Valencia
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Birmingham
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Nottingham
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00402428