Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252642
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2005-11-09
Brief Title:
Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
The Impact of Peginterferon Alpha-2a Maintenance Therapy on Portal Hypertension in Patients With Chronic Hepatitis C Virus Infection and Advanced Fibrosis and Cirrhosis Enrolled in the HALT-C Trial
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy 90 mcgweek will lower portal pressure in patients with hepatitis C virus infections and advanced fibrosis or cirrhosis
Detailed Description:
Portal hypertension develops in patients with advanced fibrosis and cirrhosis and is the primary driving force leading to complications of cirrhosis hepatic decompensation and mortality in patients with chronic liver disease None of the three major complications of advanced liver disease variceal hemorrhage ascites and hepatic encephalopathy occur in the absence of portal hypertension As a result measuring portal pressure and treating portal hypertension is an important part in the management of patients with advanced liver disease A sub-study to measure portal pressure was initially proposed as part of the HALT-C clinical trial Unfortunately only 210 centers elected to participate in this sub-study and as a result this was eventually dropped as a sub-study within the HALT-C trial
Recent data has suggested that interferon therapy may selectively reduce portal hypertension in patients with cirrhosis In an abstract presented at the 2004 annual meeting of the European Association for the Study of the Liver EASL portal pressure declined significantly in patients with NR after 6 months of treatment with peginterferon and ribavirin At the time portal pressure was measured in this study a transjugular liver biopsy was also performed to assess the effects of treatment on hepatic histology Despite a reduction in portal pressure no reduction in hepatic fibrosis score was observed This suggested that interferon may reduce portal pressure through a direct affect on the hepatic vasculature and suggests that interferon may prevent complications of cirrhosis regardless of its effects on HCV RNA and hepatic inflammation Since portal pressure is the primary factor responsible for complications of cirrhosis including variceal hemorrhage ascites and hepatic encephalopathy these preliminary results suggest that maintenance interferon therapy could possibly prevent these complications
Preliminary results form a randomized controlled trial of maintenance interferon therapy Co-Pilot presented at the 2004 annual meeting of the American Association of the study of Liver Disease AASLD did in fact demonstrate that patients with advanced fibrosis or cirrhosis who received maintenance peginterferon maintenance therapy over a two year period had a significant reduction in the incidence of variceal hemorrhage compared to that observed in the control group The HALT-C trial provides an ideal patient population in which to further assess the effects of maintenance interferon therapy on portal hypertension
The first patients who were enrolled into the HALT-C trial are scheduled to complete four years of maintenance therapy near the end of 2004 This provides an optimal time point at which to assess the impact of maintenance interferon therapy on portal pressure Although an ideal study design would have been to measure portal pressure at baseline and then again after 4 years in both the control and treatment groups measuring portal pressure at the completion of the study will still provide significant information regarding the impact of maintenance interferon therapy on portal hypertension The number of patients enrolled into HALT-C at these two sites is substantial nearly 400 patients and since the control and maintenance therapy groups were well matched at the start of the study we can assume that baseline portal pressure at the time of randomization was not significantly different in the two groups Thus if 4 years of maintenance interferon therapy does indeed reduce portal pressure a significant difference in mean portal pressure should be observed between the two groups at the completion of the HALT-C trial
Patients who were randomized to the control arm of HALT-C during the past four years have received no treatment for chronic HCV during the past 4 years Such patients will be offered the opportunity to receive peginterferon maintenance therapy for 6 months as part of this protocol and then undergo repeat measurement of portal pressure to determine if they could potentially benefit from remaining on peginterferon maintenance therapy long term
Recent data has suggested that interferon therapy may selectively reduce portal hypertension in patients with cirrhosis In an abstract presented at the 2004 annual meeting of the European Association for the Study of the Liver EASL portal pressure declined significantly in patients with NR after 6 months of treatment with peginterferon and ribavirin At the time portal pressure was measured in this study a transjugular liver biopsy was also performed to assess the effects of treatment on hepatic histology Despite a reduction in portal pressure no reduction in hepatic fibrosis score was observed This suggested that interferon may reduce portal pressure through a direct affect on the hepatic vasculature and suggests that interferon may prevent complications of cirrhosis regardless of its effects on HCV RNA and hepatic inflammation Since portal pressure is the primary factor responsible for complications of cirrhosis including variceal hemorrhage ascites and hepatic encephalopathy these preliminary results suggest that maintenance interferon therapy could possibly prevent these complications
Preliminary results form a randomized controlled trial of maintenance interferon therapy Co-Pilot presented at the 2004 annual meeting of the American Association of the study of Liver Disease AASLD did in fact demonstrate that patients with advanced fibrosis or cirrhosis who received maintenance peginterferon maintenance therapy over a two year period had a significant reduction in the incidence of variceal hemorrhage compared to that observed in the control group The HALT-C trial provides an ideal patient population in which to further assess the effects of maintenance interferon therapy on portal hypertension
The first patients who were enrolled into the HALT-C trial are scheduled to complete four years of maintenance therapy near the end of 2004 This provides an optimal time point at which to assess the impact of maintenance interferon therapy on portal pressure Although an ideal study design would have been to measure portal pressure at baseline and then again after 4 years in both the control and treatment groups measuring portal pressure at the completion of the study will still provide significant information regarding the impact of maintenance interferon therapy on portal hypertension The number of patients enrolled into HALT-C at these two sites is substantial nearly 400 patients and since the control and maintenance therapy groups were well matched at the start of the study we can assume that baseline portal pressure at the time of randomization was not significantly different in the two groups Thus if 4 years of maintenance interferon therapy does indeed reduce portal pressure a significant difference in mean portal pressure should be observed between the two groups at the completion of the HALT-C trial
Patients who were randomized to the control arm of HALT-C during the past four years have received no treatment for chronic HCV during the past 4 years Such patients will be offered the opportunity to receive peginterferon maintenance therapy for 6 months as part of this protocol and then undergo repeat measurement of portal pressure to determine if they could potentially benefit from remaining on peginterferon maintenance therapy long term
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None