CLINICAL TRIALS PROFILE FOR PEGASYS
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All Clinical Trials for PEGASYS
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00047879 ↗ | Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas | Completed | National Cancer Institute (NCI) | Phase 2 | 2002-10-01 | This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron) alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself. Stopping the growth of new vessels can slow or prevent tumor growth. The Food and Drug Administration has approved various interferons for treating several diseases, including melanoma and some leukemias. These drugs block new vessel growth in patients with recurrent tumors, but in high doses they produce serious side effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high doses given several times a week. Thalidomide, currently approved to treat leprosy, also blocks development of new blood vessel formation. In a recent study of thalidomide given to 36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least 2 months, and at least 3 had responses to treatment lasting 6 to 14 months. Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing following standard treatment and does not respond to radiation therapy may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests (including a pregnancy test for women of childbearing potential), and magnetic resonance imaging (MRI) or computed tomography (CT) of the head. Patients will continue treatment cycles as long as the drug is tolerated without serious side effects and the tumor is not growing. While on the study, patients will undergo various tests and procedures as follows: Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure. |
| NCT00048945 ↗ | Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B | Completed | Hoffmann-La Roche | Phase 3 | 2002-01-01 | The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB. |
| NCT00056862 ↗ | Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3 | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 4 | 2003-03-01 | This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure. |
| NCT00077636 ↗ | ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection. | Completed | Hoffmann-La Roche | Phase 4 | 2003-12-01 | This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. |
| NCT00077649 ↗ | A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC). | Completed | Hoffmann-La Roche | Phase 4 | 2004-01-01 | The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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