The Second Multicenter Hemophilia Cohort Study

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00341705

Collaborator

Multicenter Hemophilia Cohort Study (Other)

2,565

Enrollment

Locations

143.2

Duration (Months)

53.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Decompensation Hepatocellular Carcinoma Non-Hodgkin Lymphoma

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

2565 participants

Official Title:

The Second Multicenter Hemophilia Cohort Study

Study Start Date :

Apr 27, 2001

Study Completion Date :

Apr 2, 2013

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724
2	University of California, Davis	Davis	California	United States	95616
3	Children's Hospital of Orange County	Orange	California	United States	92613
4	University of California, San Francisco	San Francisco	California	United States	94143
5	University of Colorado	Denver	Colorado	United States	80220-3706
6	Christiana Hospital	Wilmington	Delaware	United States
7	Georgetown University	Washington	District of Columbia	United States	20007-2197
8	Childrens National Medical Center	Washington	District of Columbia	United States
9	Emory University	Atlanta	Georgia	United States	30322-1102
10	University of Illinois	Chicago	Illinois	United States	60612
11	Childrens Memorial Hospital, Chicago	Chicago	Illinois	United States	60614-3394
12	St. Vincent's Hospital	Indianapolis	Indiana	United States
13	Tulane University	New Orleans	Louisiana	United States	70112-2699
14	Wayne State University Hutzel Hospital	Detroit	Michigan	United States	48201
15	University of Minnesota	Minneapolis	Minnesota	United States	55415
16	University of Mississippi	Jackson	Mississippi	United States	39216
17	St. Louis University	Saint Louis	Missouri	United States	63104
18	University of New Mexico	Albuquerque	New Mexico	United States	87131
19	University of Buffalo	Buffalo	New York	United States
20	North Shore Long Island Jewish Health System	Lake Success	New York	United States	11042
21	Cornell University	New York	New York	United States	10021-4872
22	Mt. Sinai Medical Center	New York	New York	United States	10029-0574
23	University of North Carolina	Chapel Hill	North Carolina	United States	27599-7030
24	Wake Forest University	Winston-Salem	North Carolina	United States	27103
25	Childrens Hospital, Cinncinati	Cincinnati	Ohio	United States	45229-3039
26	University of Cincinnati	Cincinnati	Ohio	United States	45267
27	Ohio State University	Columbus	Ohio	United States	43210-1240
28	Wright State University	Dayton	Ohio	United States	45435
29	University of Oklahoma	Oklahoma City	Oklahoma	United States
30	Milton Hershey Medical Center	Hershey	Pennsylvania	United States	17033
31	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-6056
32	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107-6541
33	Palmentto Health Alliance	Columbia	South Carolina	United States	29202
34	University of Tennessee	Memphis	Tennessee	United States	38103
35	Vanderbilt University	Nashville	Tennessee	United States	37232
36	University of Texas, Houston	Houston	Texas	United States	77030
37	University of Texas, San Antonio	San Antonio	Texas	United States
38	University of Utah	Salt Lake City	Utah	United States	84112
39	Childrens Hospital of Wisconsin	Milwaukee	Wisconsin	United States
40	Hospital Brigadeiro	Sao Paulo		Brazil
41	University of Sao Paulo	Sao Paulo		Brazil
42	South East Health Care Corporation	New Brunswick		Canada
43	Hospices Civils de Lyon	Lyons		France
44	University of Bonn	Bonn		Germany
45	Laikon General Hospital of Athens	Athens		Greece
46	University of Florence	Florence		Italy
47	University de Milano	Milan		Italy
48	Karolinska Institute St. Gorans Hospital	Stockholm		Sweden