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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00050115 |
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:
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
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.
Condition |
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Aplastic Anemia |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Collection of Blood, Stool, Bone Marrow and/or Tissue Samples From Subjects With Hepatitis-Associated Aplastic Anemia |
Study Start Date: | November 2002 |
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.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Presumptive clinical diagnosis of hepatitis-associated aplastic anemia. That is, aplastic anemia within 12 months of an episode of hepatitis
Age equal to or greater than 2 years old
Ability to comprehend the investigational nature of the study and provide informed consent.
EXCLUSION CRITERIA
Suspected cholestatic or obstructed liver disease
Current diagnosis or past history of myelodysplastic syndrome, Fanconi's anemia, dyskeratosis congenita or other congenital forms of aplastic anemia.
Diagnosis of Diamond-Blackfan anemia or a constitutional marrow failure disease.
Underlying carcinoma, recent history of radiation or chemotherapy
Age less than 2 years old
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 030051, 03-H-0051 |
Study First Received: | November 21, 2002 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00050115 |
Health Authority: | United States: Federal Government |
Bone Marrow Failure Seronegative Hepatitis Fulminate Hepatitis |
Hepatitis Aplastic Anemia Hepatitis Associated Aplastic Anemia |
Hepatitis Liver Diseases Digestive System Diseases Hematologic Diseases Anemia, Aplastic |
Anemia Pancytopenia Aplastic anemia Bone Marrow Diseases |