Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028275
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-12-18
Brief Title:
Gamma Interferon Therapy for Chronic Hepatitis C
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Studies of Gamma Interferon Therapy for Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2003-11
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:
This study will test whether gamma interferon is effective in treating chronic hepatitis C infection-a long-lasting viral infection affecting the liver One-third of patients with hepatitis C infection develop cirrhosis of the liver which can lead to liver failure or liver cancer The current treatment for hepatitis C infection is pegylated alpha interferon peginterferon plus ribavirin however this treatment is successful in only about half of patients Gamma interferon works similarly to alpha interferon but through different pathways and therefore might be helpful in patients who do not respond to alpha interferon
Patients 18 years of age and older with chronic hepatitis C infection genotype 1 who did not respond to alpha interferon and ribavirin therapy may be eligible for this study Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate
Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation to determine eligibility for the study and if enrolled to begin gamma interferon therapy Screening will include a medical history and physical examination blood and urine tests and possibly chest X-ray abdominal ultrasound and psychiatric evaluation
Participants will receive injections of gamma interferon under the skin 3 times a week for 4 weeks a total of 12 injections They will be randomly assigned to receive either 100 or 200 micrograms of drug per injection Blood will be drawn just before the first injection and then 6 12 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and immune responses to treatment The amount and rapidity of decrease in virus will be compared with what occurs with alpha interferon treatment to define the relative effectiveness of gamma interferon Patients may leave the hospital at any time after the first day but must return in time for the final blood test
Patients will be seen in the clinic each week during treatment to report symptoms and drug side effects and to have blood drawn for routine tests and viral levels After the 4-week treatment is completed patients will return for follow-up visits at weeks 6 and 8 for routine blood tests
Patients 18 years of age and older with chronic hepatitis C infection genotype 1 who did not respond to alpha interferon and ribavirin therapy may be eligible for this study Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate
Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation to determine eligibility for the study and if enrolled to begin gamma interferon therapy Screening will include a medical history and physical examination blood and urine tests and possibly chest X-ray abdominal ultrasound and psychiatric evaluation
Participants will receive injections of gamma interferon under the skin 3 times a week for 4 weeks a total of 12 injections They will be randomly assigned to receive either 100 or 200 micrograms of drug per injection Blood will be drawn just before the first injection and then 6 12 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and immune responses to treatment The amount and rapidity of decrease in virus will be compared with what occurs with alpha interferon treatment to define the relative effectiveness of gamma interferon Patients may leave the hospital at any time after the first day but must return in time for the final blood test
Patients will be seen in the clinic each week during treatment to report symptoms and drug side effects and to have blood drawn for routine tests and viral levels After the 4-week treatment is completed patients will return for follow-up visits at weeks 6 and 8 for routine blood tests
Detailed Description:
We will treat 20 patients with chronic hepatitis C using gamma interferon 1b in doses of either 100 or 200 mcg thrice weekly for four weeks while monitoring them at regular timed intervals for hepatitis C virus HCV RNA levels and immunological responses to HCV antigens Patients with chronic hepatitis C will be eligible if they have failed to have responded to a previous course of alpha interferon and ribavirin and have raised serum aminotransferase levels HCV genotype 1 and HCV RNA in serum in levels greater than 10000 copiesml The 20 patients will include 10 patients who were treated and did not become HCV RNA negative during therapy Group A non-responders and 10 who were treated and became HCV RNA negative during therapy but relapsed thereafter Group B relapsers After a medical evaluation and monitoring for HCV RNA levels patients will be randomized to receive either 100 or 200 mcg of gamma interferon 1b provided by InterMune Pharmaceuticals Inc subcutaneously three times weekly for 4 weeks Patients will have blood tested for HCV RNA levels at 0 6 12 18 24 and 48 hours after the initial injection and then weekly during treatment followed by 2 and 4 weeks thereafter T cell responses to HCV antigens will be assessed before treatment after 4 weeks of therapy and again 4 weeks thereafter Patients will also be monitored for side effects and changes in routine liver tests and complete blood counts
This is a pilot study in a small number of patients which is aimed at assessing whether gamma interferon has antiviral and immunological effects against hepatitis C whether these effects appear to be dose related and whether they are similar in timing and degree to those of alpha interferon Demonstration of an antiviral effect would lead to more extensive trials in larger numbers of patients treated for longer periods
This is a pilot study in a small number of patients which is aimed at assessing whether gamma interferon has antiviral and immunological effects against hepatitis C whether these effects appear to be dose related and whether they are similar in timing and degree to those of alpha interferon Demonstration of an antiviral effect would lead to more extensive trials in larger numbers of patients treated for longer periods
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-DK-0072 | None | None | None |