DOUBLE-BLIND STUDY, WITH RANDOM ASSIGNMENT TO GROUPS OF TREATMENT, OF PARALLEL GROUPS, TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SB-497115-GR, AN AGONIST OF THE TROMBOPOYETINE RECEIVER, ADMINISTERED AT DOSES OF 30, 50 AND 75 MG IN THE FORM OF ORAL TABLETS ONCE A DAY FOR 6 WEEKS TO MAN AND ADULT WOMEN, WITH CHRONIC IMMUNE THROMBOCITOPENIC PURPLE, REFRACTORY TO TREATMENT

GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 0 人开始时间: 2005年8月15日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Diagnosis of chronic ITP at least 6 months before the count with platelet count <30,000 / p.L.
•2. Refractory patients who have not responded to one or more previous treatments or who have relapsed during the 3 months of previous treatment.
•3. Subjects on maintenance immunosuppressive therapy should be receiving a dose that has been stable for at least 1 month.
•4. No pre-existing heart disease.
•5. Normal prothrombin time (TP / INR) and activated partial thromboplastin time (aPTT), with no history of coagulation alterations other than ITP.
•6. The subject practices an acceptable method of contraception. Women (or female partners of male subjects) should not be of reproductive age, or be of reproductive age and use any of the acceptable contraceptive methods.
•7. The subject must be> 18 years old.
•8. The subject has signed and dated the written informed consent.
•9. The subject is capable of understanding and adhering to the requirements and instructions of the protocol, and intends to complete the study as planned.

•1. Any relevant clinical abnormality, different from PTI.
•2. History of thrombosis within the previous year.
•3. Women who are breastfeeding or pregnant during the screening or before the dose on Day 1.
•4. History of alcohol or drug abuse or dependence within 12 months prior to inclusion in the study.
•5. Treatment with any investigational medication in the 30 days or 5 half-lives prior to the administration of the first dose of the study medication.
•6. The subject has consumed aspirin, compounds containing aspirin, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatory drugs (NSAIDs) for> 3 consecutive days in the 2 weeks prior to the start of the study.
•7. The subject has consumed liquid antacids or chewable antacids within 48 hours prior to the first dose of the study medication or will require these medications during the 6-week dosing period.
•8. Consumption of any food or herbal supplement, except vitamin or mineral supplements, within the week prior to the start of the study.
•9. Complete cytology (HCC) or reticulocyte count outside of normal limits.
•10. History of platelet aggregation that prevents the reliable measurement of the platelet count.
•11. Any laboratory or clinical evidence of HIV infection, hepatitis C, hepatitis B or any evidence of active hepatitis at the time of subject scrutiny.

发起方

GLAXOSMITHKLINE PERU S.A.,