None listed
Conditions
Interventions
THERE ARE TWO PERIODS DURING THIS STUDY (REFER TO FIGURE 1 AND FIGURE 2):
• TREATMENT PERIOD: WEEK 0 TO WEEK 240 FOR PATIENTS FROM STUDY BCDO OR STUDY BCDV
WEEK 0 TO WEEK 168 FOR PATIENTS FROM STUDY BCDM (FIGURE 1)
• POST-TREATMENT FOLLOW-UP: 24 TO 48 WEEKS IN LENGTH FOR ALL PATIENTS (FIGURE 2)
ALL PATIENTS WILL RECEIVE OPEN-LABEL LY2127399 ADMINIS
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. HAVE COMPLETED 24 WEEKS OF PARTICIPATION IN STUDY BCDO OR STUDY BCDV, OR HAVE COMPLETED 100 WEEKS OF PARTICIPATION IN STUDY BCDM. 2. WOMEN MUST NOT BE PREGNANT, BREASTFEEDING, OR AT RISK TO BECOME PREGNANT DURING STUDY PARTICIPATION. FEMALE PATIENTS OF CHILDBEARING POTENTIAL, MUST TEST NEGATIVE FOR PREGNANCY AT THE TIME OF ENROLLMENT AND AGREE TO USE A RELIABLE METHOD OF BIRTH CONTROL OR REMAIN ABSTINENT DURING THE STUDY OR FOR AT LEAST 8 WEEKS FOLLOWING THE LAST DOSE OF STUDY DRUG, WHICHEVER IS LONGER, OR, MUST BE A FEMALE OF NON-CHILDBEARING POTENTIAL, DEFINED AS: WOMEN WHO HAVE HAD SURGICAL STERILIZATION (HYSTERECTOMY OR BILATERAL OOPHORECTOMY OR TUBAL LIGATION). - OR - WOMEN WHO ARE ≥ 60 YEARS OF AGE. -OR- WOMEN ≥ 40 AND <60 YEARS OF AGE WHO HAVE HAD A CESSATION OF MENSES FOR AT LEAST 12 MONTHS AND A FOLLICLE STIMULATING HORMONE (FSH) TEST CONFIRMING NON-CHILDBEARING POTENTIAL (≥ 40 mlU/mL). 3. HAVE GIVEN WRITTEN INFORMED CONSENT APPROVED BY LILLY OR ITS REPRESENTATIVE AND THE INSTITUTIONAL REVIEW BOARD/ETHICAL REVIEW BOARD (IRB/ERB) GOVERNING THE SITE.
Exclusion criteria
Exclusion criteria: 1. PRESENCE OF SIGNIFICANT UNCONTROLLED CEREBRO-CARDIOVASCULAR (FOR EXAMPLE: MYOCARDIAL INFARCTION [MI], UNSTABLE ANGINA, UNSTABLE ARTERIAL HYPERTENSION, SEVERE HEART FAILURE OR CEREBROVASCULAR ACCIDENT), RESPIRATORY, HEPATIC, RENAL, GASTROINTESTINAL, ENDOCRINE, HEMATOLOGIC OR NEUROPSYCHIATRIC DISORDERS OR ABNORMAL LABORATORY VALUES AT BASELINE THAT IN THE OPINION OF THE INVESTIGATOR POSE AN UNACCEPTABLE RISK TO THE PATIENT IF STUDY DRUG WOULD BE ADMINISTERED. 2. HAVE ANY OTHER CONDITION THAT RENDERS THE PATIENT UNABLE TO UNDERSTAND THE NATURE, SCOPE AND POSSIBLE CONSEQUENCES OF THE STUDY OR PRECLUDES THE PATIENT FROM FOLLOWING AND COMPLETING THE PROTOCOL, IN OPINION OF THE INVESTIGATOR. 3. ARE INVESTIGATOR SITE PERSONNEL DIRECTLY AFFILIATED WITH THIS STUDY AND/OR THEIR IMMEDIATE FAMILIES. IMMEDIATE FAMILY IS DEFINED AS A SPOUSE, PARENT, CHILD, OR SIBLING, WHETHER BIOLOGICAL OR LEGALLY ADOPTED. 4. ARE EMPLOYEES OF LILLY OR OF THIRD-PARTY ORGANIZATIONS (TPOs) INVOLVED IN STUDY WHO REQUIRE EXCLUSION OF THEIR EMPLOYEES. INVSTIGATORS MAY CONTACT LILLY OR REPRESENTATIVE WITH QUESTIONS REGARDING INCLUSION AND EXCLUSION CRITERIA.
Countries
Argentina, Australia, Brazil, Bulgaria, Colombia, Croatia, France, Germany, Greece, Hungary, India, Japan, Korea North, Lithuania, Malasya, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed