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

Phase 3

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: albumin interferon alfa-2b; Drug: peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT00411385
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-13
• Study First Posted: 2006-12-14
• Study Start: 2007-02
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2009-09-17
• Disposition First Submitted QC: 2009-09-17
• Disposition First Posted: 2009-09-22
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 933

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ribavirin	900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
2	albumin interferon alfa-2b	1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
1	albumin interferon alfa-2b	900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
2	Ribavirin	1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
3	Ribavirin	180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
3	peginterferon alfa-2a	180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (SVR)	Week 48

Secondary Outcome Measures

Name	Time	Method
Rapid virologic response	Week 4
Early virologic response	Week 12
Undetectable HCV RNA	Week 24
Normalization of ALT (a liver enzyme)	Week 48
Quality of life evaluation	Week 48
Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)	Througout the entire treatment period

Trial Locations

Locations (159)

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

University of Florida-Gainesville; 🇺🇸 Gainesville, Florida, United States

Shands Jacksonville Medical Center; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Transplant Center; 🇺🇸 Jacksonville, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

GI of Atlanta; 🇺🇸 Atlanta, Georgia, United States

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