Immune Thrombocytopenic Purpura Clinical Trial
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
Verified date | January 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | May 1, 2009 |
Est. primary completion date | May 1, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico |
United States | Georgia Cancer Specialists | Atlanta | Georgia |
United States | Case Western Reserve University School of Medicine | Cleveland | Ohio |
United States | Cleveland Clinic Foundation, Univ. of Ohio | Cleveland | Ohio |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Karmanos Cancer Center, Wertz Clinical Cancer Center 4HWCRC | Detroit | Michigan |
United States | Baptist Cancer Institute | Jacksonville | Florida |
United States | Davis, Posteraro and Wasser, MD's LLP | Manchester | Connecticut |
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 | Cancer Center of Florida | Orlando | Florida |
United States | Washington University School of Medicine - St Louis, MO | Saint Louis | Missouri |
United States | Hematology Oncology Associates of South Texas | San Antonio | Texas |
United States | University of California San Diego Medical Center | San Diego | California |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants with platelet count >= 50000/µL | Response was defined as platelet count >= 50 x1000/uL for participants without Baseline steroid uses; or platelet counts >= 50 x1000/uL and doubling the Baseline platelet counts for participants with baseline steroid uses. Confidence interval of response rate was computed using exact method of binomial proportion. | At Week 6 | |
Secondary | Number of participants with time to response by Platelet Counts (platelet counts >= 50,000/µL) | Response was defined as platelet count >= 50 x1000/uL for participants without baseline steroid uses; or platelet counts >= 50 x1000/uL and doubling the Baseline platelet counts for participants with baseline steroid uses. | Week 1, 2, 4 and 6 of part 1 | |
Secondary | Change From Baseline to Last Bleeding Observation During Double-Blind Treatment | ITP Bleeding Severity Scale was used for the analysis of bleeding score. Bleeding scores were, 0=None, 1=minor, and 2=major. Body sites and bleeding grade analysis was as follows: cutaneous (1= 1-5 bruises; scattered petechiae and 2= > 5 bruises, >2 centimeter [cm]; petechiae), oral mucosa (1= 1 blood blister or > 5 petechiae, gum bleeding < 5 minute[min], 2= multiple blood blisters; gum bleeding > 5 min), epistaxis (1= blood on blowing nose or epistaxis < 5 min, 2= bleeding > 5 min), gastrointestinal (1= occult blood, 2= gross blood), gynecological (1= spotting not at time of period, 2= bleeding not at time of period or very heavy period), urinary (1= microscopic (+ by dipstick), 2= macroscopic), pulmonary(1= possible symptoms but mild, 2= yes), subconjunctival (1= yes, 2= both eyes significantly involved), Intracranial (1= possible symptoms, 2= yes, clinically confirmed). Change from Baseline was calculated as Baseline value minus post-randomization value. Baseline was Day 1value. | Day 1 (Baseline) and Week 6 | |
Secondary | Duration of platelet counts >= 50,000/µL of LGD4665 | Response was defined as platelet count >= 50 x1000/uL for participants without baseline steroid uses; or platelet counts >= 50 x1000/uL and doubling the Baseline platelet counts.A Kaplan-Meier projection of time to response by platelet counts was analyzed. | Up to Week 6 |
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