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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR PEGINTERFERON BETA-1A

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All Clinical Trials for peginterferon beta-1a

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001854 Long-Term Therapy With Ribavirin for Chronic Hepatitis C Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 4 1999-02-01 Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. The disease can be serious and even fatal. Approximately 25% of patients with chronic hepatitis C will develop cirrhosis and some of these patients will develop cancer of the liver or liver failure. Presently the disease is treated with a combination of alpha interferon or peginterferon (antiviral and immune stimulating drugs) and ribavirin (an antiviral drug). Alpha interferon is given by injection three times a week whereas peginterferon is given by injection only once a week. Ribavirin is given as a tablet by mouth twice a day. The combination therapy is given for 6 to months. About half of the patients given these medications will receive a lasting benefit and many patients do not respond well to the combination therapy. This study will select up to 50 patients will chronic hepatitis C who have not responded to combination therapy or who could not stand the side effects associated with interferon or peginterferon therapy. These subjects will be evaluated and undergo liver biopsy to determine their present liver condition. If selected as subjects they will be started on single drug therapy with ribavirin. The drug will be given orally twice a day at a dose based on the patient's body weight. The patients will be followed on an out-patient basis. They will we asked to return for regular check-ups and blood tests every 2 to 8 weeks for the duration of the study. After 6 months, the medication will be stopped or adjusted based on the results of the subject's blood tests (liver enzymes). A response is considered if a decrease of 50% or more of the initial liver enzyme (alanine aminotransferase, ALT) is noted. A complete response will be considered if liver enzymes return to normal levels. Therapy will be discontinued after 6 months if patients do not respond. However, patients that respond to the single drug therapy will continue to receive the medication at a decreased dose. The patients will remain on an appropriate dose for up to 8 years with repeat liver biopsies at 2, 4 and 8 years to assess progress. This study will determine if long-term therapy with ribavirin is safe and effective.
NCT00006164 Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment Completed Hoffmann-La Roche Phase 3 2000-06-01 The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits. The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic HCV. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial. The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
NCT00006164 Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment Completed National Cancer Institute (NCI) Phase 3 2000-06-01 The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits. The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic HCV. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial. The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for peginterferon beta-1a

Condition Name

Condition Name for peginterferon beta-1a
Intervention Trials
Hepatitis C, Chronic 124
Hepatitis C 101
Chronic Hepatitis C 82
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Condition MeSH

Condition MeSH for peginterferon beta-1a
Intervention Trials
Hepatitis 400
Hepatitis A 343
Hepatitis C 337
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Clinical Trial Locations for peginterferon beta-1a

Trials by Country

Trials by Country for peginterferon beta-1a
Location Trials
Canada 206
Italy 125
Australia 118
Germany 113
Spain 111
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Trials by US State

Trials by US State for peginterferon beta-1a
Location Trials
California 103
Texas 99
New York 87
Florida 81
Virginia 78
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Clinical Trial Progress for peginterferon beta-1a

Clinical Trial Phase

Clinical Trial Phase for peginterferon beta-1a
Clinical Trial Phase Trials
Phase 4 134
Phase 3 121
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for peginterferon beta-1a
Clinical Trial Phase Trials
Completed 311
Terminated 41
Recruiting 31
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Clinical Trial Sponsors for peginterferon beta-1a

Sponsor Name

Sponsor Name for peginterferon beta-1a
Sponsor Trials
Hoffmann-La Roche 101
Merck Sharp & Dohme Corp. 49
Vertex Pharmaceuticals Incorporated 22
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Sponsor Type

Sponsor Type for peginterferon beta-1a
Sponsor Trials
Industry 343
Other 332
NIH 31
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