Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050115
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2002-11-21
Brief Title:
Collection of Biological Samples From Patients With Hepatitis-Associated Aplastic Anemia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Blood Stool Bone Marrow andor Tissue Samples From Subjects With Hepatitis-Associated Aplastic Anemia
Status:
COMPLETED
Status Verified Date:
2021-02
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 collect samples of blood stool bone marrow or other tissues from patients with hepatitis-associated aplastic anemia to investigate a possible association between exposure to viruses and the development of aplastic anemia in these patients Cells from the samples obtained may be grown in the laboratory for future studies Patients samples may be used to
Study abnormalities that occur in hepatitis-associated aplastic anemia
Test for various viruses
Test immune function
Measure factors related to the patients disease or diseases they may be at risk for
Evaluate the effectiveness of current therapies refine treatment approaches and identify potential new therapies
Identify possible measures for disease prevention
Identify possible genetic factors associated with hepatitis-associated aplastic anemia
Patients 2 years of age and older with severe aplastic anemia that developed within 6 months of an episode of hepatitis may be eligible for this study
Participants will complete questionnaires and provide tissue samples as described below
Questionnaires
All patients or another respondent for the patient will fill out a questionnaire including demographic information age gender race ethnic group education level state of residence current symptoms medications medical history and history of possible exposures to toxins or viruses A second questionnaire which includes questions related to mental health sexual behavior alcohol and drug use is optional for participants age 21 and older These questionnaires are designed to uncover features of hepatitis-associated aplastic anemia and possibly reveal a common cause of the disease
Sample Collections
Blood- will be collected at the time of the patient s initial evaluation or upon enrollment into the study and possibly periodically during the study Blood will be drawn through a needle in an arm vein
Bone marrow- may be collected as part of the patient s standard medical care or specifically for research purposes of this study For this procedure the skin over the hipbone and the outer surface of the bone itself are numbed with an injection of a local anesthesia Then a larger needle is inserted into the hipbone and marrow is drawn into a syringe Marrow cells are suctioned two to six times during the 15-minute procedure
Stool- will be provided by the patient
Liver- tissue may be biopsied as part of the patient s general medical care or for NIH patients as part of their enrollment in a treatment protocol
Study abnormalities that occur in hepatitis-associated aplastic anemia
Test for various viruses
Test immune function
Measure factors related to the patients disease or diseases they may be at risk for
Evaluate the effectiveness of current therapies refine treatment approaches and identify potential new therapies
Identify possible measures for disease prevention
Identify possible genetic factors associated with hepatitis-associated aplastic anemia
Patients 2 years of age and older with severe aplastic anemia that developed within 6 months of an episode of hepatitis may be eligible for this study
Participants will complete questionnaires and provide tissue samples as described below
Questionnaires
All patients or another respondent for the patient will fill out a questionnaire including demographic information age gender race ethnic group education level state of residence current symptoms medications medical history and history of possible exposures to toxins or viruses A second questionnaire which includes questions related to mental health sexual behavior alcohol and drug use is optional for participants age 21 and older These questionnaires are designed to uncover features of hepatitis-associated aplastic anemia and possibly reveal a common cause of the disease
Sample Collections
Blood- will be collected at the time of the patient s initial evaluation or upon enrollment into the study and possibly periodically during the study Blood will be drawn through a needle in an arm vein
Bone marrow- may be collected as part of the patient s standard medical care or specifically for research purposes of this study For this procedure the skin over the hipbone and the outer surface of the bone itself are numbed with an injection of a local anesthesia Then a larger needle is inserted into the hipbone and marrow is drawn into a syringe Marrow cells are suctioned two to six times during the 15-minute procedure
Stool- will be provided by the patient
Liver- tissue may be biopsied as part of the patient s general medical care or for NIH patients as part of their enrollment in a treatment protocol
Detailed Description:
Our laboratory has a long-standing interest in viruses that affect the bone marrow especially those causing bone marrow failure One specific syndrome hepatitis-associated aplastic anemia suggests that the same agent is responsible for the severe and sometimes fulminate hepatitis as well as the profound bone marrow failure This study is designed to collect clinical data and samples from patients with hepatitis-associated aplastic anemia in order to learn more about the clinical features of the disease as well as to collect blood liver bone marrow and stool samples where possible for ongoing virological studies For liver and bone marrow samples material will only be obtained when the liver or bone marrow are biopsied for other medical indications or during the removal of the liver at the time of transplantation No additional risk to the patient should result from either procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 03-H-0051 | None | None | None |