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Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Human Genome Sciences
Novartis
Information provided by: Human Genome Sciences
ClinicalTrials.gov Identifier: NCT00402428
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: albumin interferon alfa-2b
Drug: peginterferon alfa-2a
Drug: Ribavirin
Phase III

MedlinePlus related topics:   Hepatitis    Hepatitis C   

ChemIDplus related topics:   Ribavirin    Peginterferon Alfa-2a    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:
  • Sustained virologic response (SVR) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapid virologic response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Early virologic response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Undetectable HCV RNA [ Time Frame: Week 24 and Week 48 ] [ Designated as safety issue: No ]
  • Normalization of ALT (a liver enzyme) [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Quality of life evaluation [ Time Frame: throughout the entire study ] [ Designated as safety issue: No ]
  • Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing) [ Time Frame: Throughout the entire study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   1290
Study Start Date:   December 2006
Estimated Study Completion Date:   February 2009
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
Drug: peginterferon alfa-2a
180 mcg once a week for 48 weeks
Drug: Ribavirin

1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

=,> 75kg)

2: Experimental
900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Drug: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks
Drug: Ribavirin

1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

=,> 75kg)

3: Experimental
1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Drug: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks
Drug: Ribavirin

1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

=,> 75kg)


  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402428

Show 165 study locations  Show 165 Study Locations

Sponsors and Collaborators
Human Genome Sciences
Novartis

Investigators
Study Director:     Medical Monitor     Human Genome Sciences, Inc    
  More Information


Publications:

Responsible Party:   Human Genome Sciences ( Patrick Cronin )
Study ID Numbers:   HGS1008-C1060, ACHIEVE-1
First Received:   November 20, 2006
Last Updated:   March 27, 2008
ClinicalTrials.gov Identifier:   NCT00402428
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: Human Research Ethics Committee;   Austria: Agency for Health and Food Safety;   Austria: Ethikkommission;   Canada: Ethics Review Committee;   Canada: Health Canada;   Czech Republic: State Institute for Drug Control;   France: Afssaps - French Health Products Safety Agency;   France: National Consultative Ethics Committee for Health and Life Sciences;   Germany: Ethics Commission;   Germany: Federal Institute for Drugs and Medical Devices;   India: Institutional Review Board;   Israel: Ministry of Health;   Italy: Ethics Committee;   Italy: National Monitoring Centre for Clinical Trials - Ministry of Health;   Poland: Ministry of Health;   Romania: National Medicines Agency;   Spain: Spanish Agency of Medicines;   Switzerland: Ethikkommision;   Switzerland: Swissmedic;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United Kingdom: Research Ethics Committee;   United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Human Genome Sciences:
Chronic Hepatitis C  
Hepatitis C  
CHC  
HepC  
Genotype 1
Hepatitis
HCV

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on October 03, 2008




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