Status:
COMPLETED
Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation
Lead Sponsor:
GlaxoSmithKline
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 increa...
Detailed Description
This is a Phase IIA study with two parts to the design. * Part 1 is a randomized, double-blinded, placebo-controlled treatment of 7.5 mg/day LGD-4665 versus placebo in approximately 24 patients with ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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
- non-steroidal anti-inflammatory drugs (unless prescribed for heart disease)
- History of platelet aggregation that would prevent measurement of platelet counts
- Known active infection with HIV, hepatitis B, or hepatitis C
- In the Investigator's opinion, the patient is not able to comply with requirements of the study
Exclusion
Key Trial Info
Start Date :
March 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00621894
Start Date
March 15 2008
End Date
May 15 2009
Last Update
December 16 2024
Active Locations (15)
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1
University of California San Diego Medical Center
San Diego, California, United States, 92103-8409
2
University of California, San Francisco
San Francisco, California, United States, 94143-1270
3
Davis, Posteraro and Wasser, MD's LLP
Manchester, Connecticut, United States, 06040
4
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207