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

Human Genome Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: peginterferon alfa-2a; Drug: albumin interferon alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411385

HGS1008-C1067

ACHIEVE-2/3

Details and patient eligibility

About

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.

Enrollment: 933 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

933 participants in 3 patient groups

1

Experimental group

Description:

900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day

Treatment:

Drug: Ribavirin

Drug: albumin interferon alfa-2b

2

Experimental group

Description:

1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day

Treatment:

Drug: Ribavirin

Drug: albumin interferon alfa-2b

3

Active Comparator group

Description:

180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a