NCT00239733

Brief Summary

Thrombocytopenia occurs when a person's blood has a decreased number of platelets, which are cells involved in blood clotting. This condition may lead to uncontrolled bleeding and can be fatal. Thrombocytopenia commonly occurs with hepatitis C virus (HCV) infection or as a result of standard HCV treatment. Anti-D is an antibody approved by the Food and Drug Administration (FDA) for the treatment of HIV-related thrombocytopenia. The purpose of this study is to determine the safety and effectiveness of intravenous anti-D for the treatment of thrombocytopenia in patients with HCV infection who are starting or already undergoing treatment with peginterferon alfa-2 and ribavirin. This study will recruit HCV patients both with and without HIV co-infection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

May 16, 2017

Completed
Last Updated

May 16, 2017

Status Verified

April 1, 2017

Enrollment Period

4.9 years

First QC Date

October 13, 2005

Results QC Date

January 5, 2017

Last Update Submit

April 14, 2017

Conditions

ThrombocytopeniaHepatitis CHIV Infections

Keywords

HIVHCVHepatitis CThrombocytopenia

Outcome Measures

Primary Outcomes (2)

  • Frequency and Severity of Adverse Events

    Throughout study, for up to 12 weeks

  • Absolute Change in Platelet Count From Baseline

    Through Week 12

Study Arms (1)

1

EXPERIMENTAL

Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.

Drug: Anti-D

Interventions

Anti-DDRUG

30-minute infusion administered in an outpatient setting

Also known as: WinRho
1

Eligibility Criteria

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

You may qualify if:

  • HCV-infected
  • Currently on treatment for HCV OR plan to begin treatment for HCV at the start of this study
  • Platelet count less than 50,000 cells/microl
  • Hemoglobin greater than 10 g/dl OR greater than 11 g/dl if peginterferon treatment-naive
  • Red blood cells are Rh (D) antigen-positive
  • Negative Coombs direct antibody test
  • HIV-infected
  • HIV-uninfected

You may not qualify if:

  • Prior treatment with intravenous immunoglobulin (IVIG), anti-D, or other medication for the treatment of thrombocytopenia within 30 days of study entry
  • Prior serious reaction to plasma products
  • Absence of spleen
  • Evidence of thrombotic thrombocytopenic purpura (TTP) OR cause of thrombocytopenia other than HCV infection, HCV treatment, or HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital (Cornell)

New York, New York, 10021, United States

Location

Related Publications (1)

  • Ware RE, Zimmerman SA. Anti-D: mechanisms of action. Semin Hematol. 1998 Jan;35(1 Suppl 1):14-22.

    PMID: 9523745BACKGROUND

MeSH Terms

Conditions

ThrombocytopeniaHepatitis CHIV Infections

Interventions

RHO(D) antibodygamma-Globulins

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Kristen Marks
Organization
Weill Cornell
markskr@med.cornell.edu
212-746-4177

Study Officials

  • Kristen M. Marks, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

March 1, 2005

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 16, 2017

Results First Posted

May 16, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)