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ICH GCP | Clinical Trials Registry

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

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



Sponsors

Lead Sponsor

 National Heart, Lung, and Blood Institute (NHLBI)


Source

National Institutes of Health Clinical Center (CC)

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.

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.

Overall Status

Completed

Start Date

2002-11-18

Completion Date

N/A

Primary Completion Date

N/A

Study Type

Observational

Enrollment

9

Condition

 Aplastic Anemia

Eligibility

Criteria

- 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

Gender

All

Minimum Age

2 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Neal S Young, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)

Location

Facility

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

Location Countries

Country

United States


Verification Date

2018-03-21

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords

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

Has Expanded Access

No

Condition Browse

 Hepatitis,  Anemia,  Anemia, Aplastic

Secondary Id

03-H-0051

Firstreceived Results Date

N/A

Reference

Citation

Böttiger LE, Westerholm B. Aplastic anaemia. 3. Aplastic anaemia and infectious hepatitis. Acta Med Scand. 1972 Oct;192(4):323-6.

PMID

5081070


Citation

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


Citation

Young NS, Issaragrasil S, Chieh CW, Takaku F. Aplastic anaemia in the Orient. Br J Haematol. 1986 Jan;62(1):1-6.

PMID

3942690



Firstreceived Results Disposition Date

N/A

Study Design Info

Time Perspective

Prospective


Study First Submitted

November 21, 2002

Study First Submitted Qc

November 19, 2002

Study First Posted

November 20, 2002

Last Update Submitted

August 8, 2018

Last Update Submitted Qc

August 8, 2018

Last Update Posted

August 9, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

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