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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 21, 2002 |
| Last Updated Date | August 24, 2009 |
| Start Date ICMJE | November 2002 |
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00050115 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Collection of Biological Samples From Patients With Hepatitis-Associated Aplastic Anemia |
| Official Title ICMJE | Collection of Blood, Stool, Bone Marrow and/or Tissue Samples From Subjects With Hepatitis-Associated Aplastic Anemia |
| 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:
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. |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Prospective |
| Condition ICMJE | Aplastic Anemia |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 99999999 |
| Completion Date | |
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
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 |
| Gender | Both |
| Ages | 2 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00050115 |
| Responsible Party | |
| Study ID Numbers ICMJE | 030051, 03-H-0051 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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