Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation
Public ClinicalTrials.gov record NCT00621894. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIA Randomized, Double-Blind, Placebo-Controlled Study of LGD-4665 in Patients With Immune Thrombocytopenic Purpura (ITP) With an Open Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in healthy volunteers. This study will examine the safety, tolerability and efficacy of 7.5 mg capsules of LGD-4665 to increase platelets compared to placebo, randomized 2:1, during blinded treatment for 6 weeks. Evaluation of platelet counts, bleeding scores and safety parameters will be done weekly. All patients are eligible to continue on active, open LGD-4665 treatment for an additional 12 weeks with optimal adjustment of dose for each patient.
Study identification
- NCT ID
- NCT00621894
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2008 (Actual)
- Primary completion
- May 1, 2009 (Actual)
- Completion
- May 15, 2009 (Actual)
- Last update posted
- Dec 16, 2024
2008 – 2009
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Medical Center | San Diego | California | 92103-8409 | — |
| University of California, San Francisco | San Francisco | California | 94143-1270 | — |
| Davis, Posteraro and Wasser, MD's LLP | Manchester | Connecticut | 06040 | — |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | — |
| Cancer Center of Florida | Orlando | Florida | 32806 | — |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | — |
| Karmanos Cancer Center, Wertz Clinical Cancer Center 4HWCRC | Detroit | Michigan | 48201 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine - St Louis, MO | St Louis | Missouri | 63110 | — |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | — |
| Joan and Sanford I. Weill Medical College, Cornell University | New York | New York | 10021 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Case Western Reserve University School of Medicine | Cleveland | Ohio | 44106-7284 | — |
| Cleveland Clinic Foundation, Univ. of Ohio | Cleveland | Ohio | 44195 | — |
| Hematology Oncology Associates of South Texas | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00621894, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00621894 live on ClinicalTrials.gov.