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

August 21, 2007 updated by: Intarcia Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
      • Smolensk, Russian Federation
      • St. Petersburg, Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HCV RNA levels at clinically relevant timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intarcia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 17, 2004

First Submitted That Met QC Criteria

November 17, 2004

First Posted (Estimate)

November 18, 2004

Study Record Updates

Last Update Posted (Estimate)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 21, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biomed 510-CLP-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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