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MV21542 (PROPHESYS 3)

Study ID: MV21542 (PROPHESYS 3)

Sponsors: F Hoffman-La Roche Ltd.

National Institute of Health/Institute of Allergy and Infectious Diseases/Division of AIDS

Title: Prospective observational study on predictors of early on-treatment response and sustained virological response in a cohort of treatment naive HCV-infected patients treated with pegylated interferons

Summary: Men and women aged >_l8 years with serologically POPULATION proven chronic hepatitis C (all genotypes) who are to be treated with peginterferon alfa-2a (PEGASYS®) or peginterferon alfa 2b (PegIntron®) plus ribavirin according to the current standard of care in line with current summaries of product characteristics (SPCs)/local labeling.

Association of virological response 4 and 12 weeks after treatment initiation with sustained virological response (SVR) by HCV genotype and peginterferon

Phase #: Observational

Study Design: International, multicenter, prospective, non-randomized single-arm, observational, non-interventional cohort study.

Eligibility Criteria:

Inclusion Criteria:

Written informed consent. All other inclusion criteria for this cohort have to be in line with the SPCs/local labeling for peginterferon/ribavirin.

The most important criteria are:

• Male and female patients ≥ 18 years of age, infected with HCV
  
• Positive serum HCV RNA
  
• All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with peginterferon/ribavirin until 6 months post--treatment.
  

Exclusion Criteria for Observation:

• Co-infection with HBV (patients with a positive HBsAg)
  
• Previous treatment with peginterferon and/or ribavirin
  
• Participation in a therapeutic GCP clinical study within 30 days prior to study start
  
• All contraindications specified in the respective SPCs/local labeling of peginterferon/ribavirin must be adhered to.
  

The major exclusion criteria are:

• Autoimmune hepatitis
  
• Severe hepatic dysfunction or decompensated cirrhosis of the liver
  
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months
  
• Hypersensitivity to peginterferori or ribavirin or to any of the excipients
  
• Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during, treatment, please see SPCs for further details)
  
• Breast-feeding women
  
• Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)

Drugs/Treatment Provided: None

Duration: October 2007 until December 2010. The enrollment period is up to 12 months or shorter if target number has been enrolled

Compensation to Participant: None

Principal Investigator: Donna Mildvan, MD

Study Location:
Beth Israel Medical Center
AIDS Clinical Trials Unit
350 East 17th Street, 3rd Floor
New York, NY 10003

Contact Information:
Ph: 212-420-4519 or 800-483-7339

Email: Trials@BethIsraelNY-HIVtrials.org

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MV21542 (PROPHESYS 3)

Prospective observational study on predictors of early on-treatment response and sustained virological response in a cohort of treatment naive HCV-infected patients treated with pegylated interferons

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