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

Phase 3

Completed

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

• Registration Number: NCT00402428
• 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 1 who are IFNa treatment naive.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-20
• Study First Posted: 2006-11-22
• Study Start: 2006-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• 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: 1331

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	albumin interferon alfa-2b	1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
3	Ribavirin	1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
2	albumin interferon alfa-2b	900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
1	Ribavirin	180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
1	peginterferon alfa-2a	180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
2	Ribavirin	900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (SVR)	Week 72

Secondary Outcome Measures

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

Trial Locations

Locations (165)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

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

UCSF Fresno; 🇺🇸 Fresno, California, United States

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

USC Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA / West LA VAMC; 🇺🇸 Los Angeles, California, United States

Huntington Medical Research Institutes; 🇺🇸 Pasadena, California, United States

University California-San Diego; 🇺🇸 San Diego, California, United States

San Diego Digestive Diseases Consultants, Inc; 🇺🇸 San Diego, California, United States

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