Natural History Study of Non-A, Non-B Post-Transfusion Hepatitis (NANB-TAH) - Catalog
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Name
Natural History Study of Non-A, Non-B Post-Transfusion Hepatitis (NANB-TAH)
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Accession Number
HLB00901212a
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Acronym
NANB-TAH
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Related studies(TTVS) Transfusion-Transmitted Viruses Study (TTVS)
(VA2-TAH) VA Cooperative Study of the Efficacy of Hepatitis Immune Serum Globulin for the Prevention or Modification of Post-Transfusion Hepatitis (VA2-TAH)
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BSI Study IDs
NAN
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Is public use dataset
False
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Keywords
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Ingestion StatusReleased
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Has Study Datasets
True
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Has Specimens
True
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Specimen ID TypeCoded
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Study Website
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The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.
False
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Clinical Trial URLs
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Study typeEpidemiology Study
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Collection TypeOpen BioLINCC Study
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Cohort typeBoth
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Interventions
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Study Open Date (Data)
2012-03-06
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Study Open Date (Specimens)
2012-03-06
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Date materials available
2012-03-05
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Last updated
2023-02-07
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Study period
1988 - 2001
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Study Contacts
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NHLBI Division
DBDR
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ClassificationTransfusion Medicine
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HIV study classificationnon-HIV
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COVID study classificationnon-COVID
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Pre-Website # of Specimens Shipped
0
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# of Returned Specimens
0
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Primary Publication URLs
N/A
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Commercial use data restrictionsNo
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Data restrictions based on area of researchNo
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Commercial use specimen restrictionsNo
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Non-genetic use specimen restrictions based on area of useYes
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Genetic use of specimens allowed?Yes
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Genetic use area of research restrictionsYes
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Specific Consent Restrictions
Use of biospecimens is restricted to studies related to hepatitis.
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ConditionsBlood Transfusion
Hepatitis, Viral, Human
Liver Diseases
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Objectives
This extended follow-up study of 5 major prospective studies of transfusion-associated hepatitis conducted in the US between 1967 and 1980, attempted to address the uncertainty about the frequency progression to clinically symptomatic and debilitating chronic liver disease and the frequency of fatal liver disease. The study, designed to track both mortality and morbidity of transfusion-associated non-A, non-B hepatitis, was a natural history evaluation that began at the time of disease onset. It also included a concurrent control group that could be evaluated, and that the study subjects were monitored for almost 25 years.
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Background
Prior to this study, little was known about the long-term consequences of non-A, non-B hepatitis. Most studies examined the short-term prognosis following acute infection which was characterized by mild but persistent inflammation. However, reports of late-onset cirrhosis, liver failure or even hepatocellular carcinoma were accumulating from patients with more than 10 years of follow-up. The frequency, rate of development and contribution to mortality of these sequelae of transfusion-associated non-A, non-B hepatitis were not well established.
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Participants
Of the total 6438 subjects who entered the original 5 studies, that included the VA Cooperative Study of the Efficacy of Hepatitis Immune Serum Globulin for the Prevention or Modification of Post-Transfusion Hepatitis (VA2-TAH) and the Transfusion-Transmitted Viruses Study (TTVS), 1765 subjects were included in this study including 1552 non-A, non-B cases and controls (568 cases and 984 matched controls) and 213 hepatitis B cases and controls (79 cases and 134 matched controls). Thirty-eight of the non-A, non-B cases had no matched controls and seventy-six had only one control. Eight of the hepatitis B cases had no matched controls and eight had only one control.
A total of 311 subjects in the NANB-TAH study were recruited from the VA2-TAH study of which 308 subjects can be linked to the available dataset. A subset have biospecimens available from the VA2-TAH study period. A total of 501 subjects in the TTVS study subsequently were enrolled and followed in the NANB-TAH study although linkage at the subject level is no longer available.
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Design
Researchers traced patients with two control subjects with transfusion related non-A, non –B hepatitis who had been identified in 5 separate studies conducted between 1967 and 1980. Each patient was matched with two control subjects who received transfusions but did not have hepatitis. They were matched based on five categorical variables: the initial treatment center, sex, race (black or non-black), use of hepatitis immunoprophylaxis, and the presence or absence of a history of alcoholism; and three continuous variables: age, the number of units of blood transfused, and the date of transfusion. The mortality rates in the three groups were determined with use of data from National Death Index and Social Security Death Tapes. Cause specific mortality rates were determined by reviewing death certificates.
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Conclusions
The data indicated that the frequency of death from all causes among transfusion recipients whom non-A, non-B hepatitis had developed an average of 18 years earlier in virtually identical to that in a carefully matched group of transfusion recipients in whom hepatitis did not develop. There was no increase in the mortality from all causes after transfusion associated non-A, non-B hepatitis, although there was a small, but statistically significant increase in the number of deaths related to liver disease. With an additional 7 years of follow-up, the liver-related mortality rate attributable to chronic hepatitis C increased among the cases compared to the controls. Additional follow-up of subjects, restricted to the 3 studies with archived original sera was extended to approximately 25 years. There remained no increase in the mortality from all causes after transfusion associated non-A, non-B hepatitis.
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Disease classification
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Publications
Seeff LB, Buskell-Bales Z, Wright EC, Durako SJ, Alter HJ, Iber FL, Hollinger FB, Gitnick G, Knodell RG, Perrillo RP, et al. Long-term mortality after transfusion-associated non-A, non-B hepatitis. The National Heart, Lung, and Blood Institute Study Group. N Engl J Med. 1992; 327(27):1906-11.
Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000; 132(2):105-11.
Harris DR, Gonin R, Alter HJ, Wright EC, Buskell ZJ, Hollinger FB, Seeff LB; National Heart, Lung, and Blood Institute Study Group. The relationship of acute transfusion-associated hepatitis to the development of cirrhosis in the presence of alcohol abuse. Ann Intern Med. 2001; 134(2):120-4.
Lin HJ, Seeff LB, Barbosa L, Hollinger FB. Occurrence of identical hypervariable region 1 sequences of hepatitis C virus in transfusion recipients and their respective blood donors: divergence over time. Hepatology. 2001; 34(2):424-9.
Seeff LB, Hollinger FB, Alter HJ, Wright EC, Cain CM, Buskell ZJ, Ishak KG, Iber FL, Toro D, Samanta A, Koretz RL, Perrillo RP, Goodman ZD, Knodell RG, Gitnick G, Morgan TR, Schiff ER, Lasky S, Stevens C, Vlahcevic RZ, Weinshel E, Tanwandee T, Lin HJ, Barbosa L. Long-term mortality and morbidity of transfusion-associated non-A, non-B, and type C hepatitis: A National Heart, Lung, and Blood Institute collaborative study. Hepatology. 2001; 33(2):455-63.
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Mat typesSerum
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Network
The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.
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Subjects
Cases: 647
Controls: 1,118
Last Modified: March 13, 2025, 10:22 a.m. -
Age
Total Subjects
< 18
12
18-24
70
25-29
87
30-34
63
35-39
108
40-44
184
45-49
271
50-54
326
55-59
308
60-64
191
65-69
72
70-74
48
75+
25
Last Modified: March 13, 2025, 10:24 a.m. -
Sex
Total Subjects
Male
1,357
Female
408
Last Modified: March 13, 2025, 10:22 a.m. -
Race
Total Subjects
Not Black
1,483
Black
282
Last Modified: March 13, 2025, 10:22 a.m.
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request.
Section 3.0 of the BioLINCC Handbook
describes the components of the review process.
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Material Types
Serum
Last Modified: March 13, 2025, 10:22 a.m. -
General Freeze/Thaw Status
Majority of serum is unthawed
Last Modified: March 13, 2025, 10:22 a.m. -
Visits (Vials)
03/13/2025
Serum
Total Vials
Month 1
1,044
1,044
Month 2
29
29
Month 3
839
839
Month 4
13
13
Month 5
40
40
Month 6
55
55
Month 7
57
57
Month 8
88
88
Month 9
85
85
Month 10
77
77
Month 11
67
67
Month 12
62
62
Month 13
58
58
Month 14
50
50
Month 15
47
47
Month 16
46
46
Month 17
58
58
Month 18
59
59
Month 19
52
52
Month 20
45
45
Month 21
41
41
Month 22
38
38
Month 23
31
31
Month 24
21
21
Last Modified: March 13, 2025, 10:22 a.m. -
Visits (Subjects)
03/13/2025
Serum
Total number of subjects
Average volume (mL) per subject
Month 1
474
6.06
Month 2
15
6.18
Month 3
420
7.11
Month 4
8
6.44
Month 5
18
8.06
Month 6
25
8.24
Month 7
28
7.49
Month 8
38
8.43
Month 9
39
7.42
Month 10
33
8.65
Month 11
30
8.18
Month 12
32
6.04
Month 13
31
5.57
Month 14
25
6.91
Month 15
25
5.56
Month 16
25
5.14
Month 17
27
6.12
Month 18
26
7.15
Month 19
25
6.66
Month 20
19
8.32
Month 21
18
7.69
Month 22
16
8.91
Month 23
13
9.96
Month 24
8
11.44
Last Modified: March 13, 2025, 10:22 a.m.