Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000093482
Ethics application status
Approved
Date submitted
13/12/2006
Date registered
29/01/2007
Date last updated
19/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Albumin Interferon Alfa-2b with Ribavirin Compared to Peg-Interferon Alfa-2a with Ribavirin in interferon Naive Patients, Genotype-1
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 Chronic Hepatitis C (CHC) Genotype 1 to improve Sustained virologic response. ACHIEVE-1
Secondary ID [1] 337 0
Human Genome Sciences: HGS1008-C1060
Secondary ID [2] 338 0
ClinicalTrials.gov: NCT00402428
Universal Trial Number (UTN)
Trial acronym
ACHIEVE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatits C 1591 0
Condition category
Condition code
Oral and Gastrointestinal 1694 1694 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
Subcutaneous injections of albumin interferon alfa-2b 900mcg or 1200mcg every 2 weeks and oral administration of ribavirin 1000 or 1200mg daily. Duration: 48 week treatment.
Intervention code [1] 1476 0
Treatment: Drugs
Comparator / control treatment
Subcutaneously injection of peginterferon alfa-2a 180mcg weekly and oral administration of ribavirin 1000 or 1200mg daily. Duration: 48 week treatment.
Control group
Active

Outcomes
Primary outcome [1] 2346 0
Sustained virologic response (SVR).
Timepoint [1] 2346 0
Week 72.
Secondary outcome [1] 4084 0
Rapid virologic response
Timepoint [1] 4084 0
at Week 4
Secondary outcome [2] 4085 0
Early virologic response
Timepoint [2] 4085 0
at Week 12
Secondary outcome [3] 4086 0
Undetectable hepatitis C virus ribonucleic acid (HCV RNA)
Timepoint [3] 4086 0
at Week 24 and Week 48
Secondary outcome [4] 4087 0
Normalization of ALT (a liver enzyme) over the duration of the study
Timepoint [4] 4087 0
Day 0, Weeks 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 52, 60, 72
Secondary outcome [5] 4088 0
Quality of life evaluation throughout the duration of the study
Timepoint [5] 4088 0
Day 0, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 60
Secondary outcome [6] 4089 0
Safety assessments throughout the duration of the study
Timepoint [6] 4089 0
Day 0, Weeks 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 52, 60, 72

Eligibility
Key inclusion criteria
Key Inclusion Criteria: 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)
central randomisation by Interactive Voice Response System (IVRS)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software. Stratified allocation. Stratification factors are HCV RNA (>800,000 or <800,000) at screening, Body Mass Index (BMI) at Day 0, Race (Black/African American or all others).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1290
Accrual to date
Final
Recruitment outside Australia
Country [1] 437 0
United States of America
State/province [1] 437 0

Funding & Sponsors
Funding source category [1] 1834 0
Commercial sector/Industry
Name [1] 1834 0
Novartis
Country [1] 1834 0
Primary sponsor type
Commercial sector/Industry
Name
Human Genome Sciences, Inc
Address
Country
United States of America
Secondary sponsor category [1] 1654 0
Commercial sector/Industry
Name [1] 1654 0
Human Genome Sciences Europe GmbH
Address [1] 1654 0
Country [1] 1654 0
Secondary sponsor category [2] 1655 0
Commercial sector/Industry
Name [2] 1655 0
Human Genome Sciences Pacific Pty Ltd.
Address [2] 1655 0
Country [2] 1655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3433 0
Metropolitan Research
Ethics committee address [1] 3433 0
Fairfax, Virginia, United States 22031
Ethics committee country [1] 3433 0
United States of America
Date submitted for ethics approval [1] 3433 0
Approval date [1] 3433 0
Ethics approval number [1] 3433 0
Ethics committee name [2] 3434 0
University of Florida - Gainesville
Ethics committee address [2] 3434 0
Gainesville, Florida, United States 32610
Ethics committee country [2] 3434 0
United States of America
Date submitted for ethics approval [2] 3434 0
Approval date [2] 3434 0
Ethics approval number [2] 3434 0

Summary
Brief summary
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27410 0
Address 27410 0
Country 27410 0
Phone 27410 0
Fax 27410 0
Email 27410 0
Contact person for public queries
Name 10665 0
Thomas Platek
Address 10665 0
14200 Shady Grove Road
Rockville MD 20850
Country 10665 0
United States of America
Phone 10665 0
1-866-447-9749
Fax 10665 0
Email 10665 0
Thomas_Platek@hgsi.com
Contact person for scientific queries
Name 1593 0
Thomas Platek
Address 1593 0
14200 Shady Grove Road
Rockville MD 20850
Country 1593 0
United States of America
Phone 1593 0
1-866-447-9749
Fax 1593 0
Email 1593 0
Thomas_Platek@hgsi.com

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

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