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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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:

  • 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 heal

Detailed Summary: 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.
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: November 21, 2002
Date Started: November 16, 2002
Date Completion:
Last Updated: April 20, 2017
Last Verified: March 29, 2017