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Trial record 30 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00411385
Recruitment Status : Completed
First Posted : December 14, 2006
Last Update Posted : August 8, 2013
Information provided by (Responsible Party):
Human Genome Sciences Inc.

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 2/3 who are IFNa treatment naive.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: albumin interferon alfa-2b Drug: peginterferon alfa-2a Drug: Ribavirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 933 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.
Study Start Date : February 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Drug: albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks

Drug: Ribavirin
800mg/day for 24 weeks

Experimental: 2
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Drug: albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks

Drug: Ribavirin
800mg/day for 24 weeks

Active Comparator: 3
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
Drug: peginterferon alfa-2a
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks

Drug: Ribavirin
800mg/day for 24 weeks

Primary Outcome Measures :
  1. Sustained virologic response (SVR) [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Rapid virologic response [ Time Frame: Week 4 ]
  2. Early virologic response [ Time Frame: Week 12 ]
  3. Undetectable HCV RNA [ Time Frame: Week 24 ]
  4. Normalization of ALT (a liver enzyme) [ Time Frame: Week 48 ]
  5. Quality of life evaluation [ Time Frame: Week 48 ]
  6. Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results) [ Time Frame: Througout the entire treatment period ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 2/3.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00411385

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Sponsors and Collaborators
Human Genome Sciences Inc.
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Study Director: GSK Clinical Trials GlaxoSmithKline

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Human Genome Sciences Inc. Identifier: NCT00411385     History of Changes
Other Study ID Numbers: HGS1008-C1067
First Posted: December 14, 2006    Key Record Dates
Last Update Posted: August 8, 2013
Last Verified: August 2013
Keywords provided by Human Genome Sciences Inc.:
Chronic Hepatitis C
Hepatitis C
Genotype 1
Additional relevant MeSH terms:
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Interferon alpha-2
Peginterferon alfa-2a
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs