Liver DecompensationNCT00341705
The Second Multicenter Hemophilia Cohort Study
An observational study of Liver Decompensation and Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 48 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Liver Decompensation, Hepatocellular Carcinoma, Non-Hodgkin Lymphoma
- How many people
- 2,565 participants
- Where
- 48 sitesin 8 countries
- Study dates
- 27 Apr 2001to 2 Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 8 countries.
48 sites in 8 countries
United States39 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30322-1102
University of Buffalo
Buffalo, New York
University of North Carolina
Chapel Hill, North Carolina, 27599-7030
University of Illinois
Chicago, Illinois, 60612
Childrens Memorial Hospital, Chicago
Chicago, Illinois, 60614-3394
Childrens Hospital, Cinncinati
Cincinnati, Ohio, 45229-3039
University of Cincinnati
Cincinnati, Ohio, 45267
Palmentto Health Alliance
Columbia, South Carolina, 29202
Ohio State University
Columbus, Ohio, 43210-1240
University of California, Davis
Davis, California, 95616
Wright State University
Dayton, Ohio, 45435
University of Colorado
Denver, Colorado, 80220-3706
Wayne State University Hutzel Hospital
Detroit, Michigan, 48201
Milton Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas, Houston
Houston, Texas, 77030
St. Vincent's Hospital
Indianapolis, Indiana
University of Mississippi
Jackson, Mississippi, 39216
North Shore Long Island Jewish Health System
Lake Success, New York, 11042
University of Tennessee
Memphis, Tennessee, 38103
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin
University of Minnesota
Minneapolis, Minnesota, 55415
Vanderbilt University
Nashville, Tennessee, 37232
Tulane University
New Orleans, Louisiana, 70112-2699
Cornell University
New York, New York, 10021-4872
Mt. Sinai Medical Center
New York, New York, 10029-0574
University of Oklahoma
Oklahoma City, Oklahoma
Children's Hospital of Orange County
Orange, California, 92613
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6056
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-6541
University of Utah
Salt Lake City, Utah, 84112
University of Texas, San Antonio
San Antonio, Texas
University of California, San Francisco
San Francisco, California, 94143
St. Louis University
St Louis, Missouri, 63104
University of Arizona
Tucson, Arizona, 85724
Georgetown University
Washington D.C., District of Columbia, 20007-2197
Childrens National Medical Center
Washington D.C., District of Columbia
Christiana Hospital
Wilmington, Delaware
Wake Forest University
Winston-Salem, North Carolina, 27103
About this study
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.
Read the 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.
- Keywords
- AIDS, Cancer, Hepatitis C Virus, HIV, Natural History, Hemophilia, Hepatitis C
- Medical subject headings
- Hepatic Insufficiency, Carcinoma, Hepatocellular, Lymphoma, Non-Hodgkin, Acquired Immunodeficiency Syndrome, Neoplasms, Hepatitis C, Hemophilia A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start27 Apr 2001
- Study completion2 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver DecompensationStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Multicenter Hemophilia Cohort Study
- Investigators
- James J Goedert, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341705
- Sponsor's protocol ID
- 999901170
- Other IDs
- 01-C-N170
- Status last verified
- 2 Apr 2013
- First submitted
- 19 Jun 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.
PubMed 10595759Kroner 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.
PubMed 8106967Eyster 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.
PubMed 8098752
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Multicenter Hemophilia Cohort Study
- ClinicalTrials.gov ID
- NCT00341705
- Acronym / sponsor ID
- 999901170
- Keywords
- AIDS, Cancer, Hepatitis C Virus, HIV, Natural History, Hemophilia, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,565 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Multicenter Hemophilia Cohort Study
- Study start
- 27 Apr 2001
- Study completion
- 2 Apr 2013
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 10595759Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.
- Background: PubMed 8106967Kroner 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.
- Background: PubMed 8098752Eyster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Goedert, M.D. principal investigator
National Cancer Institute (NCI)
48 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Decompensation and Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 48 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Brazil, Italy, Canada, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341705, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.