A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols. - NCT00800735-21205 (Clinical Trial 256963)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy256963.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21205 |
| Conditions: |
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Hepatitis C, Chronic |
| Purpose: |
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This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or
in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have
participated in a previous Roche or Roche partner protocol where access to treatment or
re-treatment was promised or deemed appropriate following completion of the original
protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin
PEGASYS monotherapy,at a maximum dose of 180 micrograms weekly, or combination therapy with
Copegus ,800-1200mg daily, as continuation of treatment after the wash-out period defined in
their donor protocol. PEGASYS treatment is not to exceed approved treatment duration of 24
weeks in genotype 2/3 and 48 weeks in genotype non-2/3 with a treatment-free follow up
period of 24 weeks. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- adult patients, >=18 years of age;
- CHC patients with compensated liver disease (Child-Pugh A) who have participated in a
donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or
in combination with Copegus was promised or deemed appropriate after completion of
the donor protocol.
Exclusion Criteria:
- evidence of decompensated liver disease (Child B or C cirrhosis). |
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| Study is available at: |
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Baltimore, MD 21205
United States
Primary Contact:
Please reference Study ID Number: NV21928
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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