CompletedPhase 4

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

United States337 participantsStarted 2013-06-10

Plain-language summary

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushing's Disease or Acromegaly), and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives.
✓. Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator
✓. Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.
✓. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
✓. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication.

Exclusion criteria

✕. Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
✕. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
✕. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either:

What they're measuring

Incidence of Adverse Events to Evaluate Long Term Safety Data

Timeframe: Baseline up to approximately 10 years

Trial details

NCT IDNCT01794793

SponsorRECORDATI GROUP

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-25

Results submitted2024-07-16

View on ClinicalTrials.gov More Cushing's Disease trials