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

NCT00050115 | Completed

• 2 other identifiers: 03005103-H-0051
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hepatitis-Associated Aplastic Anemia

Keywords

Bone Marrow Failure; Seronegative Hepatitis; Fulminate Hepatitis; Hepatitis; Aplastic Anemia; Hepatitis Associated Aplastic Anemia

Outcome Measures

Primary Outcomes (1)

• to characterize hepatitis disease in subjects with aplastic anemia

  To characterize hepatitis disease in subjects with aplastic anemia

  Indefinite

Study Arms (1)

Hepatitis A + AA cohort

Subjects seen either at Clinical center or by outside physician

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bottiger LE, Westerholm B. Aplastic anaemia. 3. Aplastic anaemia and infectious hepatitis. Acta Med Scand. 1972 Oct;192(4):323-6. No abstract available.

  PMID: 5081070 BACKGROUND

• Mary JY, Baumelou E, Guiguet M. Epidemiology of aplastic anemia in France: a prospective multicentric study. The French Cooperative Group for Epidemiological Study of Aplastic Anemia. Blood. 1990 Apr 15;75(8):1646-53.

  PMID: 2183887 BACKGROUND

• Young NS, Issaragrasil S, Chieh CW, Takaku F. Aplastic anaemia in the Orient. Br J Haematol. 1986 Jan;62(1):1-6. doi: 10.1111/j.1365-2141.1986.tb02893.x. No abstract available.

  PMID: 3942690 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Bone Marrow Failure Disorders; Hepatitis; Anemia, Aplastic

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Digestive System Diseases; Anemia

Study Officials

• Neal S Young, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2002
• First Posted: November 20, 2002
• Study Start: March 10, 2003
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

US (1)