NCT00007371

Brief Summary

To define the natural history, immunologic, and genetic factors that influence the clinical outcome of hepatitis C in a cohort of hemophilic siblings.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 28, 2000

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2000

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

September 26, 2016

Status Verified

January 1, 2005

Enrollment Period

4.9 years

First QC Date

December 19, 2000

Last Update Submit

September 22, 2016

Conditions

Blood DiseaseHemophilia AHepatitis, Viral, Human

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (9)

  • Kweon YO, Goodman ZD, Dienstag JL, Schiff ER, Brown NA, Burchardt E, Schoonhoven R, Brenner DA, Fried MW. Decreasing fibrogenesis: an immunohistochemical study of paired liver biopsies following lamivudine therapy for chronic hepatitis B. J Hepatol. 2001 Dec;35(6):749-55. doi: 10.1016/s0168-8278(01)00218-5.

    PMID: 11738102BACKGROUND

  • Nelson DR, Soldevila-Pico C, Reed A, Abdelmalek MF, Hemming AW, Van der Werf WJ, Howard R, Davis GL. Anti-interleukin-2 receptor therapy in combination with mycophenolate mofetil is associated with more severe hepatitis C recurrence after liver transplantation. Liver Transpl. 2001 Dec;7(12):1064-70. doi: 10.1053/jlts.2001.29414.

    PMID: 11753908BACKGROUND

  • Fried MW. Side effects of therapy of hepatitis C and their management. Hepatology. 2002 Nov;36(5 Suppl 1):S237-44. doi: 10.1053/jhep.2002.36810.

    PMID: 12407599BACKGROUND

  • Fried MW, Peter J, Hoots K, Gaglio PJ, Talbut D, Davis PC, Key NS, White GC, Lindblad L, Rickles FR, Abshire TC. Hepatitis C in adults and adolescents with hemophilia: a randomized, controlled trial of interferon alfa-2b and ribavirin. Hepatology. 2002 Oct;36(4 Pt 1):967-72. doi: 10.1053/jhep.2002.35529.

    PMID: 12297845BACKGROUND

  • Nelson DR, Tu Z, Soldevila-Pico C, Abdelmalek M, Zhu H, Xu YL, Cabrera R, Liu C, Davis GL. Long-term interleukin 10 therapy in chronic hepatitis C patients has a proviral and anti-inflammatory effect. Hepatology. 2003 Oct;38(4):859-68. doi: 10.1053/jhep.2003.50427.

    PMID: 14512873BACKGROUND

  • Liu C, Zhu H, Tu Z, Xu YL, Nelson DR. CD8+ T-cell interaction with HCV replicon cells: evidence for both cytokine- and cell-mediated antiviral activity. Hepatology. 2003 Jun;37(6):1335-42. doi: 10.1053/jhep.2003.50207.

    PMID: 12774012BACKGROUND

  • Zhu H, Zhao H, Collins CD, Eckenrode SE, Run Q, McIndoe RA, Crawford JM, Nelson DR, She JX, Liu C. Gene expression associated with interferon alfa antiviral activity in an HCV replicon cell line. Hepatology. 2003 May;37(5):1180-8. doi: 10.1053/jhep.2003.50184.

    PMID: 12717400BACKGROUND

  • Cabrera R, Tu Z, Xu Y, Firpi RJ, Rosen HR, Liu C, Nelson DR. An immunomodulatory role for CD4(+)CD25(+) regulatory T lymphocytes in hepatitis C virus infection. Hepatology. 2004 Nov;40(5):1062-71. doi: 10.1002/hep.20454.

    PMID: 15486925BACKGROUND

  • Theodore D, Fried MW, Kleiner DE, Kroner BL, Goedert JJ, Eyster ME, Faust SP, Sherman KE, Kessler CM, Francis C, Aledort LM. Liver biopsy in patients with inherited disorders of coagulation and chronic hepatitis C. Haemophilia. 2004 Sep;10(5):413-21. doi: 10.1111/j.1365-2516.2004.00919.x.

    PMID: 15357765BACKGROUND

MeSH Terms

Conditions

Hematologic DiseasesHemophilia AHepatitis, Viral, Human

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVirus DiseasesInfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Michael Fried

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2000

First Posted

November 28, 2000

Study Start

September 1, 1999

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

September 26, 2016

Record last verified: 2005-01

Data Sharing

IPD Sharing
Will not share