A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response. - NCT00623428-32803 (Clinical Trial 204298)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy204298.aspx
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| City: |
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Orlando |
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State:
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FL |
| Zip Code: |
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32803 |
| Conditions: |
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Hepatitis C, Chronic |
| Purpose: |
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This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy
given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.
Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do
not achieve a rapid viral response at week 4 will enter the study between treatment week 6
and 8, and will receive study medication. Those who have an early virological response at
week 12, and are still taking medication at week 24, will then be randomized to one of 2
study groups. Group 1 will stop treatment at this point and will have a 48 week
post-treatment observation period, and Group 2 will stay on medication for a further 24
weeks, followed by a 24 week post-treatment observation period. The anticipated time on
study treatment is 6-12 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;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no RVR;
- compensated liver disease.
Exclusion Criteria:
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to
initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or HIV;
- history or other evidence of decompensated liver disease. |
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| Study is available at: |
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Orlando, FL 32803
United States
Primary Contact:
Please reference Study ID Number: MV21371
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 15, 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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