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

NCT00097045 | Completed Phase 2

• 1 other identifier: Biomed 510-CLP-07
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; HCV; Omega Interferon; Interferon; HCV genotype 1

Outcome Measures

Primary Outcomes (1)

• HCV RNA levels at clinically relevant timepoints

Interventions

omega interferon DRUG

Ribavirin DRUG

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• the use of an approved contraceptive method (e.g., IUD, oral contraceptive, or double-barrier method), or
• For women of childbearing potential, negative serum Beta HCG pregnancy test within 14 days prior to randomization

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (3)

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Smolensk, Russia

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

interferon omega 1; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2004
• First Posted: November 18, 2004
• Study Start: November 1, 2004
• Study Completion: December 1, 2006
• Last Updated: August 23, 2007

Record last verified: 2007-08

Locations

RU (3)