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The Second Multicenter Hemophilia Cohort Study

Primary Purpose

Liver Decompensation, Hepatocellular Carcinoma, Non-Hodgkin Lymphoma

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Liver Decompensation focused on measuring AIDS, Cancer, Hepatitis C Virus, HIV, Natural History, Hemophilia, Hepatitis C

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Must be registered patient with an inherited coagulation disorder at a participating MHCS-II center. Disorders include hemophilia A or B (congenital factor VIII or IX deficiency), deficiencies in other factors such as V or XI, and vonWillebrand's disease. (Unless noted otherwise, all of the disorders will collectively be referred to as hemophilia .) All such hemophilia and vonWillebrand s disease patients are to be recruited as study participants. Since January 1, 1993, must have had at least one positive result on a licensed assay for HCV antibodies, HIV antibodies, or HIV RNA. Must be at least 13 years of age at enrollment. Must provide signed informed consent or, for minors, signed assent plus signed informed consent from the parent or guardian. EXCLUSION CRITERIA: Is not a patient with an inherited coagulation disorder. Does not have a positive test for HCV antibodies, HIV antibodies, or HIV RNA on a licensed assay performed since January 1, 1993. Is less than 13 years of age. Lacks informed consent/assent.

Sites / Locations

  • University of Arizona
  • University of California, Davis
  • Children's Hospital of Orange County
  • University of California, San Francisco
  • University of Colorado
  • Christiana Hospital
  • Georgetown University
  • Childrens National Medical Center
  • Emory University
  • University of Illinois
  • Childrens Memorial Hospital, Chicago
  • St. Vincent's Hospital
  • Tulane University
  • Wayne State University Hutzel Hospital
  • University of Minnesota
  • University of Mississippi
  • St. Louis University
  • University of New Mexico
  • University of Buffalo
  • North Shore Long Island Jewish Health System
  • Cornell University
  • Mt. Sinai Medical Center
  • University of North Carolina
  • Wake Forest University
  • Childrens Hospital, Cinncinati
  • University of Cincinnati
  • Ohio State University
  • Wright State University
  • University of Oklahoma
  • Milton Hershey Medical Center
  • University of Pennsylvania
  • Thomas Jefferson University
  • Palmentto Health Alliance
  • University of Tennessee
  • Vanderbilt University
  • University of Texas, Houston
  • University of Texas, San Antonio
  • University of Utah
  • Childrens Hospital of Wisconsin
  • Hospital Brigadeiro
  • University of Sao Paulo
  • South East Health Care Corporation
  • Hospices Civils de Lyon
  • University of Bonn
  • Laikon General Hospital of Athens
  • University of Florence
  • University de Milano
  • Karolinska Institute St. Gorans Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2006
Last Updated
December 14, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Multicenter Hemophilia Cohort Study
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1. Study Identification

Unique Protocol Identification Number
NCT00341705
Brief Title
The Second Multicenter Hemophilia Cohort Study
Official Title
The Second Multicenter Hemophilia Cohort Study
Study Type
Observational

2. Study Status

Record Verification Date
April 2, 2013
Overall Recruitment Status
Completed
Study Start Date
April 27, 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2, 2013 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Multicenter Hemophilia Cohort Study

4. Oversight

5. Study Description

Brief Summary
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.
Detailed Description
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Decompensation, Hepatocellular Carcinoma, Non-Hodgkin Lymphoma
Keywords
AIDS, Cancer, Hepatitis C Virus, HIV, Natural History, Hemophilia, Hepatitis C

7. Study Design

Enrollment
2565 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Must be registered patient with an inherited coagulation disorder at a participating MHCS-II center. Disorders include hemophilia A or B (congenital factor VIII or IX deficiency), deficiencies in other factors such as V or XI, and vonWillebrand's disease. (Unless noted otherwise, all of the disorders will collectively be referred to as hemophilia .) All such hemophilia and vonWillebrand s disease patients are to be recruited as study participants. Since January 1, 1993, must have had at least one positive result on a licensed assay for HCV antibodies, HIV antibodies, or HIV RNA. Must be at least 13 years of age at enrollment. Must provide signed informed consent or, for minors, signed assent plus signed informed consent from the parent or guardian. EXCLUSION CRITERIA: Is not a patient with an inherited coagulation disorder. Does not have a positive test for HCV antibodies, HIV antibodies, or HIV RNA on a licensed assay performed since January 1, 1993. Is less than 13 years of age. Lacks informed consent/assent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Goedert, M.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92613
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220-3706
Country
United States
Facility Name
Christiana Hospital
City
Wilmington
State/Province
Delaware
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
Facility Name
Childrens National Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1102
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Childrens Memorial Hospital, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614-3394
Country
United States
Facility Name
St. Vincent's Hospital
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Wayne State University Hutzel Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021-4872
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029-0574
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7030
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Childrens Hospital, Cinncinati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Wright State University
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45435
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Milton Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-6056
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-6541
Country
United States
Facility Name
Palmentto Health Alliance
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29202
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas, San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Hospital Brigadeiro
City
Sao Paulo
Country
Brazil
Facility Name
University of Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
South East Health Care Corporation
City
New Brunswick
Country
Canada
Facility Name
Hospices Civils de Lyon
City
Lyons
Country
France
Facility Name
University of Bonn
City
Bonn
Country
Germany
Facility Name
Laikon General Hospital of Athens
City
Athens
Country
Greece
Facility Name
University of Florence
City
Florence
Country
Italy
Facility Name
University de Milano
City
Milan
Country
Italy
Facility Name
Karolinska Institute St. Gorans Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
10595759
Citation
Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.
Results Reference
background
PubMed Identifier
8106967
Citation
Kroner BL, Rosenberg PS, Aledort LM, Alvord WG, Goedert JJ. HIV-1 infection incidence among persons with hemophilia in the United States and western Europe, 1978-1990. Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1994 Mar;7(3):279-86.
Results Reference
background
PubMed Identifier
8098752
Citation
Eyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. The Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1993 Jun;6(6):602-10.
Results Reference
background

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The Second Multicenter Hemophilia Cohort Study

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