Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502788
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2007-07-16
Brief Title:
Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia The HepC Study
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Thalassemia Clinical Research Network - Hepatitis C Clinical Trial
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HepC
Brief Summary:
Hepatitis C is one of the most common causes of long-term liver disease in the United States Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C infection The purpose of this study is to evaluate the safety of these two medications in adults with hepatitis C and thalassemia a type of blood disorder
Detailed Description:
Hepatitis C is an inflammation of the liver that is caused by infection with the hepatitis C virus Over time people may develop liver failure liver cancer or cirrhosis a condition in which the liver may become permanently scarred Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C Ribavirin stops the hepatitis C virus from spreading inside the body and peginterferon alfa-2a decreases the amount of hepatitis C virus in the body Individuals with thalassemia an inherited blood disorder that can cause anemia often receive regular blood transfusions as part of their treatment These individuals may have an increased risk of developing hepatitis C as a result of blood transfusions received before routine hepatitis C blood screening was available Treating thalassemia patients with standard hepatitis C therapy can be difficult because ribavirin can worsen anemia However omitting ribavirin then increases the risk of hepatitis C relapse following treatment The purpose of this study is to evaluate the safety of ribavirin and peginterferon alfa-2a for treating hepatitis C in adults with thalassemia
This study will enroll adults with thalassemia and long-term hepatitis C Participants will attend study visits weekly for 4 weeks every 2 weeks until Week 24 every 4 weeks until Week 48 and then every 6 weeks until Week 72 All participants will receive a peginterferon alfa-2a injection once a week and ribavirin daily Participants with the hepatitis C genotype 1 will receive 48 weeks of treatment participants with all other genotypes of the disease will receive 24 weeks of treatment A liver biopsy will occur at baseline and Week 48 The following will occur at selected study visits physical exam blood and urine collection hearing and vision screening chest x-ray heart rate monitoring and questionnaires to assess hepatitis C symptoms quality of life and depression Participants with liver iron levels greater than 20 mgg will undergo an echocardiogram ultrasound test every 3 months to monitor the heart
This study will enroll adults with thalassemia and long-term hepatitis C Participants will attend study visits weekly for 4 weeks every 2 weeks until Week 24 every 4 weeks until Week 48 and then every 6 weeks until Week 72 All participants will receive a peginterferon alfa-2a injection once a week and ribavirin daily Participants with the hepatitis C genotype 1 will receive 48 weeks of treatment participants with all other genotypes of the disease will receive 24 weeks of treatment A liver biopsy will occur at baseline and Week 48 The following will occur at selected study visits physical exam blood and urine collection hearing and vision screening chest x-ray heart rate monitoring and questionnaires to assess hepatitis C symptoms quality of life and depression Participants with liver iron levels greater than 20 mgg will undergo an echocardiogram ultrasound test every 3 months to monitor the heart
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 |
|---|---|---|---|
| U01HL065238-07 | NIH | None | httpsreporternihgovquickSearchU01HL065238-07 |
| U01HL065238 | NIH | None | None |