An open label study to assess the long term safety of the study drug, ISIS 766720, in patients with acromegaly (a hormonal disorder that results from too much growth hormone in the body)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
2. Randomized in index trial ISIS 766720-CS2 and completed the entire study, or completion of the Treatment Period for ISIS 766720-CS2 and completed or plan to complete PTWK5 visit with an acceptable safety profile, per Investigator judgment
3. Patients with confirmed stable monthly regimen of SRL for 3 months prior to Screening
4. Able and willing to participate in a 53-week Treatment and 14-week Post-Treatment study
5. Females must be non-pregnant and non-lactating, and either
a. surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
b. post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females = 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and follicle stimulating hormone (FSH) levels in the postmenopausal range for the laboratory involved)
c. abstinent or
d. Women of childbearing potential (WOCBP) should agree to taking all precaution to avoid pregnancy during the Trial Period (including Post-Treatment), including agreeing to receive pregnancy testing before each monthly dose, using 1 highly effective method of birth control from the time of signing the informed consent form until 14 weeks after the last dose of Study Drug administration
5. Males must be surgically sterile, abstinent or, if engaged in sexual relations with a female of child-bearing potential, the patient or the patient’s non-pregnant female partner must be using 1 highly effective contraceptive method from the time of signing the informed consent form until 14 weeks after the last dose of Study Drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study
2. Treatment with any investigational drug, biological agent or device other than ISIS 766720 within 1 month of screening, or 5 half-lives of the investigational agent; whichever is longer.
3. Treatment with any other acromegaly medications taken prior to Day 1 within the time period listed below:
bromocriptine: 2 weeks
carbergoline: 4 weeks
quinagolide: 4 weeks
pegvisomant: 4 weeks
pasireotide: 4 months
4. Patients who received surgery for pituitary adenoma in the last 3 months prior to screening and patients needing and/or planning to receive surgery for the pituitary adenoma during the trial
5. Unwilling to comply with required study procedures during the Treatment and Post-Treatment Periods
6. Screening laboratory assessments for chemistry, urinalysis, or hematology that have been confirmed and meet the study-specified monitoring or stopping rules. Results approaching monitoring rules will need to be reviewed by the Investigator and Sponsor Medical Monitor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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