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

Follow-Up Study in Patients with Acromegaly Previously Participating in Chiasma Study CH-ACM-01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001292-51-DE

Enrollment

Registered

2015-04-08

Start date

2015-06-30

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly MedDRA version: 17.1 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Name: Octreolin Pharmaceutical Form: Capsule INN or Proposed INN: Octreotide CAS Number: 79517-01-4 Other descriptive name: OCTREOTIDE ACETATE Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 23

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this follow-up study is to assess octreotide capsules treatment outcomes through acromegaly treatment and documented disease control, in patients who previously participated in the Chiasma CH-ACM-01 study. ;Secondary Objective: Not applicable;Primary end point(s): The outcome measures and endpoints will be as follows: • Number and proportion of patients treated with parenteral somatostatin analogs or GH receptor antagonists or dopamine agonists, at the time of the assessment, out of those patients who previously participated in the CH-ACM-01 study, and had not restarted acromegaly therapy during the two week follow-up period; and • Number and proportion of patients who re-initiated treatment due to clinical or biochemical uncontrolled disease or due to the patient known disease history, out of those patients who responded to octreotide capsules at the end of the treatment period of the CH-ACM-01 study (Core + Extension) and who restarted parenteral treatment, during the two week follow-up period. ;Timepoint(s) of evaluation of this end point: Not Applicable	—

Measure

Time frame

Main Objective: The objective of this follow-up study is to assess octreotide capsules treatment outcomes through acromegaly treatment and documented disease control, in patients who previously participated in the Chiasma CH-ACM-01 study. ;Secondary Objective: Not applicable;Primary end point(s): The outcome measures and endpoints will be as follows: • Number and proportion of patients treated with parenteral somatostatin analogs or GH receptor antagonists or dopamine agonists, at the time of the assessment, out of those patients who previously participated in the CH-ACM-01 study, and had not restarted acromegaly therapy during the two week follow-up period; and • Number and proportion of patients who re-initiated treatment due to clinical or biochemical uncontrolled disease or due to the patient known disease history, out of those patients who responded to octreotide capsules at the end of the treatment period of the CH-ACM-01 study (Core + Extension) and who restarted parenteral treatment, during the two week follow-up period. ;Timepoint(s) of evaluation of this end point: Not Applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable	—

Countries

Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Serbia, Slovakia, Slovenia, United Kingdom

Contacts

Public ContactMedpace Regulatory Submissions

Medpace, Inc.

regsubmissions@medpace.com4989895 57 180

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026