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Last Updated: February 26, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR SYLATRON

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All Clinical Trials for SYLATRON

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00018031 Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2001-06-01 This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT01432535 Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655) Completed Merck Sharp & Dohme Corp. Phase 1 2011-11-01 This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.
NCT01496807 Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma Active, not recruiting Merck Sharp & Dohme Corp. Phase 1 2012-03-01 The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.
NCT01496807 Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma Active, not recruiting H. Lee Moffitt Cancer Center and Research Institute Phase 1 2012-03-01 The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.
NCT02112032 Treatment of Advanced Melanoma With MK-3475 and Peginterferon Recruiting Melanoma Research Alliance Phase 1 2014-08-01 This study is to test how safe it is to give the combination of PEG IFN-α2b (SYLATRON) and MK-3475, an investigational drug, to patients with advanced melanoma. Its effectiveness against melanoma will also be evaluated.
NCT02112032 Treatment of Advanced Melanoma With MK-3475 and Peginterferon Recruiting Merck Sharp & Dohme Corp. Phase 1 2014-08-01 This study is to test how safe it is to give the combination of PEG IFN-α2b (SYLATRON) and MK-3475, an investigational drug, to patients with advanced melanoma. Its effectiveness against melanoma will also be evaluated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SYLATRON

Condition Name

Condition Name for SYLATRON
Intervention Trials
Melanoma 2
Hepatitis C 1
Advanced Cholangiocarcinoma 1
Renal Insufficiency 1
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Condition MeSH

Condition MeSH for SYLATRON
Intervention Trials
Melanoma 2
Infection 1
HIV Infections 1
Hepatitis C 1
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Clinical Trial Locations for SYLATRON

Trials by Country

Trials by Country for SYLATRON
Location Trials
United States 4
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Trials by US State

Trials by US State for SYLATRON
Location Trials
District of Columbia 1
Pennsylvania 1
Florida 1
Maryland 1
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Clinical Trial Progress for SYLATRON

Clinical Trial Phase

Clinical Trial Phase for SYLATRON
Clinical Trial Phase Trials
Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for SYLATRON
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for SYLATRON

Sponsor Name

Sponsor Name for SYLATRON
Sponsor Trials
Merck Sharp & Dohme Corp. 4
Hassane M. Zarour, MD 1
Melanoma Research Alliance 1
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Sponsor Type

Sponsor Type for SYLATRON
Sponsor Trials
Other 7
Industry 4
NIH 1
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