An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of FASLODEX fulvestrant in Girls with Progressive Precocious Puberty Associated with McCune Albright Syndrome - D6992C00044

ASTRAZENECA0 个研究点目标入组 30 人开始时间: 2007年2月5日最近更新: 2024年1月15日

研究概览

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•1. Diagnosis of McCune-Albright Syndrome based on having the following clinical criteria Precocious puberty evident before the age of 8 years And at least one of the following clinical criteria Cafe au lait spots Fibrous dysplasia Confirmation of Gsa mutation 2. Progressive precocious puberty associated with MAS. Progressive precocious puberty will be defined as o An increase of at least one in the breast Tanner Stage over the observation period and/or o The development or persistence of vaginal bleeding during the observation period. 3. At least one of the following two criteria must also be fulfilled o Advanced bone age defined as, bone age of at least 12 months beyond chronological age at the time of screening. o Rapid growth rate A growth rate over the observation period that is more than 2 standard deviations above the mean for age, where the growth rate is defined as the change in height or length in cm divided by the change in time annualized over years .
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Male gender 2. Any prior treatment of PPP associated with MAS with fulvestrant 3. Concomitant treatment of PPP associated with MAS, with the exception of bisphosphonates for fibrous dysplasia and GnRH analogs in the case of CPP 4. Liver function tests AST, ALT at screening 3 the upper limit of the reference range for age 5. Platelet count at screening less than 100 109/L 6. International normalized ratio INR greater than 1.6. 7. History of bleeding diathesis or long-term anticoagulant therapy other than antiplatelet therapy 8. Any severe concomitant condition that makes it undesirable for the patient to participate in this study 9. Known hypersensitivity to any component of the study drug product

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