Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation

Completed · Phase 2 · Has a placebo group

Conditions studied: Immune Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID

NCT00621894

Run by

GlaxoSmithKline

People needed

23

Starts

2008-03-15

Expected to finish

2009-05-15

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years or older
• Diagnosis of ITP for at least 3 months consistent with ASH guidelines
• Treated with one or more prior therapies for ITP and platelet counts < 30,000/µL or < 50,000/µL if on a stable oral corticosteroid for ≥ 4 weeks, supported by 2 platelet counts in prior 30 days
• Laboratory results within normal range except for the following analytes
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil counts > 1000/mL
• ALT ≤ 1.5X ULN
• AST ≤ 1.5X ULN
• Creatinine < 1.5X ULN
• Bilirubin < 1.5X ULN
• BUN < 1.5X ULN
• PT < 1.5X ULN
• aPTT <1.5X ULN
• Women of child-bearing potential must have a negative serum pregnancy test within 4 days prior to the first dose of study treatment and agree to practice an approved method of contraception or abstinence from sexual intercourse.
• Willing to sign a written informed consent

You may not qualify if…

• History of heart attack or cardiovascular disease
• Known history of arterial or venous thrombosis
• More than 3 risk factors for thromboembolic events (diabetes, smoker, using oral contraception, using estrogen therapy, hypertriglyceridemia, average cholesterol > 240 mg/dL, treatment for hypertension)
• Active cancer or a history of bone marrow disorders
• Women who are pregnant or nursing
• History of alcohol/drug abuse or dependence within one year
• Listed medications dosed within:
• 4 weeks of the first dose of the study treatment:
• Use of Rituximab
• Use of cytotoxic agents
• Use of Cyclosporine and other immunomodulators
• Use of an investigational drug
• 2 weeks of the first dose of the study treatment:
• Use of Danazol
• Use of Azathioprine
• Use of Mycophenolate mofetil and pulsed-dose steroids
• 1 week of the first dose of the study treatment:
• Use of Anti-D (WinRho®)
• Use of IVIG
• Had a platelet transfusion
• Use of herbal/dietary supplements (excluding vitamins and mineral supplements)
• 3 days of the first dose of the study treatment
• Use of aspirin, aspirin containing compounds
• salicylates
• milk of magnesia

Where it is running

• University of California San Diego Medical Center — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Davis, Posteraro and Wasser, MD's LLP — Manchester, Connecticut, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Cancer Center of Florida — Orlando, Florida, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Karmanos Cancer Center, Wertz Clinical Cancer Center 4HWCRC — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine - St Louis, MO — St Louis, Missouri, United States
• New Mexico Oncology Hematology Consultants — Albuquerque, New Mexico, United States
• Joan and Sanford I. Weill Medical College, Cornell University — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Case Western Reserve University School of Medicine — Cleveland, Ohio, United States
• Cleveland Clinic Foundation, Univ. of Ohio — Cleveland, Ohio, United States
• Hematology Oncology Associates of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.