Hepatitis CNCT00252642
Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C
A study testing Peginterferon Alpha-2a in people with Hepatitis C and Cirrhosis, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus infections and advanced fibrosis or cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Cirrhosis, Fibrosis
- What is being tested?
- Peginterferon Alpha-2a
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of HALT-C Trial, in either treatment or non-treatment arm
Who cannot join
- Non-completion of HALT-C Trial
- Patients who do not wish to be treated with peginterferon after the first portal pressure measurement
- Hepatocellular Carcinoma
- Underlying autoimmune disorder
- Currently being treated with immune suppressive agent
- Illicit drug use
Show all 10Show fewer
- Alcohol use of more than 6 grams per day
- Advanced cardiopulmonary disease
- Uncontrolled diabetes mellitus
- Patients who, in the opinion of the investigator, should not participate in this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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
The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus infections and advanced fibrosis or cirrhosis.
Read the 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 2/10 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
- Conditions
- Hepatitis C, Cirrhosis, Fibrosis
- Being tested
- Peginterferon Alpha-2a
- Keywords
- Hepatitis C, Interferon, Cirrhosis, Liver Disease, Portal Hypertension, Portal Pressure
- Medical subject headings
- Hepatitis C, Fibrosis, Liver Diseases, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Alpha-2aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in portal pressure after 6 moths of treatment with peginterferon alfa-2a will be calculated by comparing portal pressure at the end of HALT-C to values obtained after 6 months of peginterferon.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Mitchell L. Shiffman, MD, Principal investigator, Virignia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252642
- Sponsor's protocol ID
- PH-VCU-05
- Status last verified
- Mar 2017
- First submitted
- 9 Nov 2005
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.
PubMed 10451460Charlton M. Hepatitis C infection in liver transplantation. Am J Transplant. 2001 Sep;1(3):197-203. doi: 10.1034/j.1600-6143.2001.001003197.x.
PubMed 12102252Poynard T, McHutchison J, Manns M, Trepo C, Lindsay K, Goodman Z, Ling MH, Albrecht J. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology. 2002 May;122(5):1303-13. doi: 10.1053/gast.2002.33023.
PubMed 11984517Imai Y, Kawata S, Tamura S, Yabuuchi I, Noda S, Inada M, Maeda Y, Shirai Y, Fukuzaki T, Kaji I, Ishikawa H, Matsuda Y, Nishikawa M, Seki K, Matsuzawa Y. Relation of interferon therapy and hepatocellular carcinoma in patients with chronic hepatitis C. Osaka Hepatocellular Carcinoma Prevention Study Group. Ann Intern Med. 1998 Jul 15;129(2):94-9. doi: 10.7326/0003-4819-129-2-199807150-00005.
PubMed 9669992Shiffman ML, Hofmann CM, Contos MJ, Luketic VA, Sanyal AJ, Sterling RK, Ferreira-Gonzalez A, Mills AS, Garret C. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology. 1999 Nov;117(5):1164-72. doi: 10.1016/s0016-5085(99)70402-6.
PubMed 10535880Lee WM, Dienstag JL, Lindsay KL, Lok AS, Bonkovsky HL, Shiffman ML, Everson GT, Di Bisceglie AM, Morgan TR, Ghany MG, Morishima C, Wright EC, Everhart JE; HALT-C Trial Group. Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders. Control Clin Trials. 2004 Oct;25(5):472-92. doi: 10.1016/j.cct.2004.08.003.
PubMed 15465617Garcia N Jr, Sanyal AJ. Portal hypertension. Clin Liver Dis. 2001 May;5(2):509-40. doi: 10.1016/s1089-3261(05)70176-8.
PubMed 11385974
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00252642
- Acronym / sponsor ID
- PH-VCU-05
- Conditions
- Hepatitis C, Cirrhosis, Fibrosis
- Keywords
- Hepatitis C, Interferon, Cirrhosis, Liver Disease, Portal Hypertension, Portal Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) 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 2/10 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of HALT-C Trial, in either treatment or non-treatment arm
Key exclusion criteria (10 listed)
- Non-completion of HALT-C Trial
- Patients who do not wish to be treated with peginterferon after the first portal pressure measurement
- Hepatocellular Carcinoma
- Underlying autoimmune disorder
- Currently being treated with immune suppressive agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon Alpha-2a | Drug | – |
Primary outcome
Changes in portal pressure after 6 moths of treatment with peginterferon alfa-2a will be calculated by comparing portal pressure at the end of HALT-C to values obtained after 6 months of peginterferon.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Background: PubMed 10451460Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.
- Background: PubMed 12102252Charlton M. Hepatitis C infection in liver transplantation. Am J Transplant. 2001 Sep;1(3):197-203. doi: 10.1034/j.1600-6143.2001.001003197.x.
- Background: PubMed 11984517Poynard T, McHutchison J, Manns M, Trepo C, Lindsay K, Goodman Z, Ling MH, Albrecht J. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology. 2002 May;122(5):1303-13. doi: 10.1053/gast.2002.33023.
- Background: PubMed 9669992Imai Y, Kawata S, Tamura S, Yabuuchi I, Noda S, Inada M, Maeda Y, Shirai Y, Fukuzaki T, Kaji I, Ishikawa H, Matsuda Y, Nishikawa M, Seki K, Matsuzawa Y. Relation of interferon therapy and hepatocellular carcinoma in patients with chronic hepatitis C. Osaka Hepatocellular Carcinoma Prevention Study Group. Ann Intern Med. 1998 Jul 15;129(2):94-9. doi: 10.7326/0003-4819-129-2-199807150-00005.
- Background: PubMed 10535880Shiffman ML, Hofmann CM, Contos MJ, Luketic VA, Sanyal AJ, Sterling RK, Ferreira-Gonzalez A, Mills AS, Garret C. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology. 1999 Nov;117(5):1164-72. doi: 10.1016/s0016-5085(99)70402-6.
- Background: PubMed 15465617Lee WM, Dienstag JL, Lindsay KL, Lok AS, Bonkovsky HL, Shiffman ML, Everson GT, Di Bisceglie AM, Morgan TR, Ghany MG, Morishima C, Wright EC, Everhart JE; HALT-C Trial Group. Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders. Control Clin Trials. 2004 Oct;25(5):472-92. doi: 10.1016/j.cct.2004.08.003.
- Background: PubMed 11385974Garcia N Jr, Sanyal AJ. Portal hypertension. Clin Liver Dis. 2001 May;5(2):509-40. doi: 10.1016/s1089-3261(05)70176-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell L. Shiffman, MD principal investigator
Virignia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon Alpha-2a in people with Hepatitis C and Cirrhosis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in portal pressure after 6 moths of treatment with peginterferon alfa-2a will be calculated by comparing portal pressure at the end of HALT-C to values obtained after 6 months of peginterferon.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252642, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.