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Collection of Biological Samples From Patients With Hepatitis-Associated Aplastic Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050115
Recruitment Status : Completed
First Posted : November 20, 2002
Last Update Posted : February 8, 2021
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.


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.

Condition or disease
Hepatitis-Associated Aplastic Anemia

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.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Collection of Blood, Stool, Bone Marrow and/or Tissue Samples From Subjects With Hepatitis-Associated Aplastic Anemia
Actual Study Start Date : March 10, 2003
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine

Hepatitis A + AA cohort
Subjects seen either at Clinical center or by outside physician

Primary Outcome Measures :
  1. to characterize hepatitis disease in subjects with aplastic anemia [ Time Frame: Indefinite ]
    To characterize hepatitis disease in subjects with aplastic anemia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinical

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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00050115

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Neal S Young, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT00050115    
Other Study ID Numbers: 030051
First Posted: November 20, 2002    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Bone Marrow Failure
Seronegative Hepatitis
Fulminate Hepatitis
Aplastic Anemia
Hepatitis Associated Aplastic Anemia
Additional relevant MeSH terms:
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Hepatitis A
Anemia, Aplastic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hematologic Diseases
Bone Marrow Diseases