NCT00006301

Brief Summary

This study will identify and characterize immune factors involved in hepatitis C infection and elimination of the virus. Individual responses to hepatitis C infection vary; some people are able to eliminate the virus, whereas others remain chronically infected. This study may identify factors important in preventing infection that may be of help in developing a vaccine or more effective treatments. People over 18 years old who have been exposed to hepatitis C virus may participate in this study. Subjects will be recruited from the National Institutes of Health, Inova Fairfax Hospital, Occupational Medical Services-IDP P.C., Washington Hospital Center and Holy Cross Hospital, all in the Washington, D.C. metropolitan area. Individual patients from other centers will also be recruited on a case by case basis. Participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. The first collection will be as soon as possible after exposure to hepatitis C virus and then again at 2, 4, 6, 12, 24, and 48 weeks after exposure. The white blood cells will be studied for their response to the virus, and markers for infection will be followed. If infection develops, additional samples of blood may be requested, and patients will be offered evaluation for treatment. Test results will be kept confidential and will not be entered into any medical records.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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 24, 2000

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2000

Completed
14.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2015

Completed
Last Updated

December 3, 2019

Status Verified

March 24, 2015

First QC Date

September 27, 2000

Last Update Submit

November 30, 2019

Conditions

Hepatitis C

Keywords

Hepatitis CViral SequencePCRT CellSeroconversionCytokines

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female;
  • All ethnic groups;
  • Age above 18 years;
  • Defined exposure to hepatitis C.

You may not qualify if:

  • Subjects with a Hct of less than 30.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Holy Cross Hospital, Silver Spring

Silver Spring, Maryland, 20902, United States

Location

Occupational Medicine Services

Annandale, Virginia, 22003, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (3)

  • Puro V, Petrosillo N, Ippolito G. Risk of hepatitis C seroconversion after occupational exposures in health care workers. Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections. Am J Infect Control. 1995 Oct;23(5):273-7. doi: 10.1016/0196-6553(95)90056-x.

    PMID: 8585637BACKGROUND

  • Arai Y, Noda K, Enomoto N, Arai K, Yamada Y, Suzuki K, Yoshihara H. A prospective study of hepatitis C virus infection after needlestick accidents. Liver. 1996 Oct;16(5):331-4. doi: 10.1111/j.1600-0676.1996.tb00755.x.

    PMID: 8938635BACKGROUND

  • Mizuno Y, Suzuki K, Mori M, Hayashi K, Owaki T, Hayashi H, Kumada K, Ohba K, Mizokami M. Study of needlestick accidents and hepatitis C virus infection in healthcare workers by molecular evolutionary analysis. J Hosp Infect. 1997 Feb;35(2):149-54. doi: 10.1016/s0195-6701(97)90103-1.

    PMID: 9049819BACKGROUND

MeSH Terms

Conditions

Hepatitis CHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Theo Heller, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2000

First Posted

September 28, 2000

Study Start

September 24, 2000

Study Completion

March 24, 2015

Last Updated

December 3, 2019

Record last verified: 2015-03-24

Locations

US(5)