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

February 4, 2021 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Collection of Blood, Stool, Bone Marrow and/or Tissue Samples From Subjects With Hepatitis-Associated Aplastic Anemia

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary clinical

Description

  • INCLUSION CRITERIA

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to characterize hepatitis disease in subjects with aplastic anemia
Time Frame: Indefinite
To characterize hepatitis disease in subjects with aplastic anemia
Indefinite

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2003

Primary Completion (Actual)

June 24, 2019

Study Completion (Actual)

June 24, 2019

Study Registration Dates

First Submitted

November 21, 2002

First Submitted That Met QC Criteria

November 19, 2002

First Posted (Estimate)

November 20, 2002

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030051
  • 03-H-0051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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