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

Phase 2 Study of Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097045

Enrollment

Registered

2004-11-18

Start date

2004-11-30

Completion date

2006-12-31

Last updated

2007-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, HCV, Omega Interferon, Interferon, HCV genotype 1

Brief summary

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.

Detailed description

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

Interventions

DRUGomega interferon

DRUGRibavirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
HCV RNA levels at clinically relevant timepoints	—

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026