Follow-Up Study in Patients that Participated in the Chiasma Study CH-ACM-01

• Conditions: Acromegaly; MedDRA version: 18.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-001292-51-SI
• Lead Sponsor: Chiasma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Patients who received at least one dose of octreotide capsules during CH ACM-01;
2. Patients who did not re-initiate medical treatment for acromegaly within the two week follow-up period OR patients who have been responders (IGF-1 less than or equal to 1.3 × ULN and GH <2.5 ng/mL at the end of treatment in the CH-ACM-01 study) and re-initiated treatment within the two week follow-up period. (Note: A list of patients that meet the above inclusion criteria will be provided by the Sponsor); and
Patients are able to understand and sign written informed consent to participate in the study.

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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified