NCT00107913

Brief Summary

This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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, 2001

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2005

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2005

First QC Date

April 11, 2005

Last Update Submit

June 23, 2005

Conditions

Autoimmune Thrombocytopenic Purpura

Keywords

Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • the primary outcome would be a platelet response, with a return of platelet count to normal

Interventions

DoxilDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes.
  • Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids.
  • Platelet count of 30,000 or less.
  • Performance status score of 2 or less.
  • Adequate organ function: \*bilirubin\< 2; \*AST \< 3 times normal; \*creatinine \< 2.
  • No prior treatment with anthracycline or chemically related drugs.

You may not qualify if:

  • Pregnant or lactating women.
  • Presence of a malignancy other than basal cell carcinoma of the skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology and Oncology Specialists

Metairie, Louisiana, 70006, United States

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Thomas M Cosgriff, MD

    Hematology and Oncology Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2005

First Posted

April 12, 2005

Study Start

September 1, 2001

Study Completion

April 1, 2005

Last Updated

June 24, 2005

Record last verified: 2005-04

Locations

US(1)