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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
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)
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
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Royal Melbourne Hospital - Parkville
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Fremantle Hospital - Fremantle
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Sir Charles Gairdner Hospital - Nedlands
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Royal Perth Hospital - Perth
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2050 - Camperdown
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2139 - Concord
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2217 - Kogarah
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2305 - New Lambton
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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
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3081 - Heidelburg
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
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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
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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
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
https://clinicaltrials.gov/show/NCT00402428
Trial related presentations / publications
Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naïve patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. Epub 2006 May 30.
Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. Epub 2006 Jan 30.
S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006
Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006
Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.
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

Summary results
Other publications