Other Studies
MV21542 (PROPHESYS 3)
Sponsor:
F Hoffman-La Roche Ltd. National Institute of Health/Institute of Allergy and Infectious Diseases/Division of AIDS
Study 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
Compensation:
None
Study Duration: October 2007 until December 2010. The enrollment period is up to 12 months or shorter if target number has been enrolled
Principal Investigator: Donna Mildvan, M.D.
Study Location: Beth Israel Medical Center Infectious Diseases/AIDS Clinical Trials Unit 350 East 17th Street, 3rd floor New York, NY, 10003
Contact Information: Phone: 212-420-4519 or 800-483-7339 Email
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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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