NCT00005305

Brief Summary

To elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver disease in patients with hemophilia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1987

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1987

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1991

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1991

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

4 years

First QC Date

May 25, 2000

Last Update Submit

June 13, 2016

Conditions

Study Arms (1)

Hemophilic individuals

Subjects receiving multiple blood products for treatment of hemophilia

Other: No interventions - observational study

Interventions

Hemophilic individuals

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 (5)

  • Wang JG, Lemon SM. Hepatitis delta virus antigen forms dimers and multimeric complexes in vivo. J Virol. 1993 Jan;67(1):446-54. doi: 10.1128/JVI.67.1.446-454.1993.

    PMID: 7677957BACKGROUND
  • Andes AA, Smiley ML, White II, et al: Hepatitis Delta in Hemophiliacs: Preliminary Observation in Hepatitis B Antigen Positive and Negative Patients. In: Hepadna Viruses, Alan R. Liss, Inc., pp 619-627. 1987

    RESULT
  • Wang JG, Jansen RW, Brown EA, Lemon SM. Immunogenic domains of hepatitis delta virus antigen: peptide mapping of epitopes recognized by human and woodchuck antibodies. J Virol. 1990 Mar;64(3):1108-16. doi: 10.1128/JVI.64.3.1108-1116.1990.

  • Rozzelle JE Jr, Wang JG, Wagner DS, Erickson BW, Lemon SM. Self-association of a synthetic peptide from the N terminus of the hepatitis delta virus protein into an immunoreactive alpha-helical multimer. Proc Natl Acad Sci U S A. 1995 Jan 17;92(2):382-6. doi: 10.1073/pnas.92.2.382.

  • Lemon SM, Becherer PR, Wang JG, White GC, Lesesne H, Janco RL, Hanna WT, Davis C, Johnson CA, Poon MC, et al. Hepatitis delta infection among multiply-transfused hemophiliacs. Prog Clin Biol Res. 1991;364:351-60. No abstract available.

MeSH Terms

Conditions

Hematologic DiseasesHepatitis, Viral, HumanLiver DiseasesHemophilia A

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesVirus DiseasesInfectionsHepatitisDigestive System DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Stanley M Lemon, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

September 1, 1987

Primary Completion

September 1, 1991

Study Completion

September 1, 1991

Last Updated

June 14, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share