Status:
COMPLETED
Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cushing Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide ...
Eligibility Criteria
Inclusion
- Participants who have completed the 15 days of Pasireotide treatment in the CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol. Participants who did not achieve normalization of 24 -hour urinary free cortisol may be enrolled if in the opinion of the investigator the participant is getting significant clinical benefits from treatment with Pasireotide .
- The participant did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment.
- Female participants of childbearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy or tubal ligation must agree to use barrier contraception throughout the course of the extension study, and for one month after the study has ended.
Exclusion
- Participant who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or hemoglobin (Hgb) A1C (HgbA1C) \> 10 since starting \[study CSOM230B2208\].
- Participant with persistent alanine aminotransferase (ALT)/ aspartate transaminase (AST) or alkaline phosphatase levels more than 2.5X upper limit of normal (ULN), serum creatinine \> 2.0 X ULN, serum bilirubin \> 2 X ULN.
- Participant with abnormal coagulation (Prothrombin time (PT) and partial thromboplastin time (PTT) elevated by 30% above normal limits), white blood cells (WBC) \<3.0x1'000'000'000/L; Hgb \<12.0g/dL for females, Hgb \<13.0g/dL for males; PLT \<100x1'000'000'000/L.
- Other protocol-defined inclusion / exclusion criteria may apply.
Key Trial Info
Start Date :
August 13 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00171951
Start Date
August 13 2004
End Date
July 8 2013
Last Update
June 2 2021
Active Locations (8)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
Portland, Oregon, United States, 97239
3
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-6149
4
Novartis Investigative Site
Paris, France, 75006