Last updated: 12/13/2024 12:10:08
Oral LGD-4665 Versus Placebo in Adults with immune thrombocytopenic purpura (ITP) for 6 Weeks plus Open Treatment Continuation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with platelet count >= 50000/µL
Timeframe: At Week 6
Secondary outcomes:
Number of participants with time to response by Platelet Counts (platelet counts >= 50,000/µL)
Timeframe: Week 1, 2, 4 and 6 of part 1
Change From Baseline to Last Bleeding Observation During Double-Blind Treatment
Timeframe: Day 1 (Baseline) and Week 6
Duration of platelet counts >= 50,000/µL of LGD4665
Timeframe: Up to Week 6
Interventions:
Drug: LGD-4665
Drug: Placebo
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
2009-01-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Immune Thrombocytopenic Purpura
Product
LGD-4665
Collaborators
Not applicable
Study date(s)
March 2008 to May 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Adults 18 years or older
- Diagnosis of ITP for at least 3 months consistent with ASH guidelines
- History of heart attack or cardiovascular disease
- Known history of arterial or venous thrombosis
Inclusion and exclusion criteria
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
Trial location(s)
Location
Joan and Sanford I. Weill Medical College, Cornell University
New York, NY, United States, 10021
Status
Study Complete
Location
Mount Sinai School of Medicine
New York, NY, United States, 10029
Status
Study Complete
Location
Cleveland Clinic Foundation, Univ. of Ohio
Cleveland, OH, United States, 44195
Status
Study Complete
Location
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Status
Study Complete
Location
University of California San Diego Medical Center
San Diego, CA, United States, 92103-8409
Status
Study Complete
Location
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
Status
Study Complete
Location
Baptist Cancer Institute
Jacksonville, FL, United States, 32207
Status
Study Complete
Location
Washington University School of Medicine - St Louis, MO
St. Louis, MO, United States, 63110
Status
Study Complete
Location
University of California, San Francisco
San Francisco, CA, United States, 94143-1270
Status
Study Complete
Location
Case Western Reserve University School of Medicine
Cleveland, Ohio, United States, 44106-7284
Status
Study Complete
Location
Davis, Posteraro and Wasser, MD's LLP
Manchester, CT, United States, 06040
Status
Study Complete
Location
Hematology Oncology Associates of South Texas
San Antonio, TX, United States, 78229
Status
Study Complete
Location
Karmanos Cancer Center, Wertz Clinical Cancer Center 4HWCRC
Detroit, MI, United States, 48201
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2009-01-05
Actual study completion date
2009-15-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study L4665-03 can be found on the GSK Clinical Study Register.
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