Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C

Intarcia Therapeutics

Status and phase

Completed

Phase 2

Conditions

Hepatitis C

Treatments

Drug: Ribavirin

Drug: omega interferon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00097045

Biomed 510-CLP-07

Details and patient eligibility

About

This study is designed to compare the safety, tolerability and antiviral effects of omega interferon administered alone to omega interferon administered with ribavirin in the treatment of subjects with chronic Hepatitis C virus (HCV) infection.

Full description

Omega interferon is administered subcutaneously daily for up to 48 weeks.

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Age 18 years to 64 years
Signed and dated written informed consent form
Infection with HCV genotype 1
Two HCV RNA levels greater than or equal to 100,000 International Units per mL (IU/mL) at least seven days apart within 6 weeks prior to randomization
One alanine aminotransferase level greater than the upper limit of normal between three months and twelve months prior to randomization
At least one alanine aminotransferase level greater than the upper limit of normal between three months and twelve months prior to randomization
For the duration of treatment with study drug for all subjects and for the duration of treatment with study drug plus an additional six months for subjects who take ribavirin, attenuation of the potential of the subject to become pregnant, or to impregnate a sexual partner, by either:
1. the use of an approved contraceptive method (e.g., IUD, oral contraceptive, or double-barrier method), or
2. definitive exclusion by surgery, radiation, menopause or vasectomy
For women of childbearing potential, negative serum Beta HCG pregnancy test within 14 days prior to randomization

Exclusion criteria

Any additional plausible cause for chronic liver disease, including active infection by other viruses known or suspected to cause hepatitis
Ascites or other current evidence of portal hypertension
Child-Pugh classification B or C liver disease
Clinically apparent jaundice or a total bilirubin exceeding 2 mg/dL (Subjects with Gilbert's Syndrome who meet all other inclusion and exclusion criteria may be admitted to the study with a total bilirubin greater than 2 mg/dL)
Hemoglobin <12 g/dL
A platelet count of less than 100,000 per mm3
A total white blood cell count of less than 3,000 per mm3
An absolute neutrophil count of less than 1,500 per mm3
Abnormal thyroid function (Subjects requiring thyroid replacement and who have stable, normal thyroid function may be admitted to the study)
History of significant renal dysfunction
History of significant or unstable cardiac disease
Concurrent alcohol abuse or illicit drug use
Pregnant or lactating women
Male partners of women who are pregnant
Prior usage of an interferon
Concurrent usage of any antiviral therapy, including another interferon, during the study
Any concurrent infectious disease requiring antimicrobial treatment
Positive test for human immunodeficiency virus
Positive test for illicit drugs
A history of malignancy (except for previously cured squamous cell or basal cell carcinoma)
Known hypersensitivity to interferons or ribavirin or related compounds
A concurrent diagnosis of depression that has not been stable for at least 60 days prior to randomization
Usage of an investigational drug within the 30 days prior to randomization; or the planned usage of an investigational drug other than omega interferon during the course of the current study
Prior randomization to this study
Any condition which, at the discretion of the investigator, would render an individual an inappropriate candidate for this study