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

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2015-001292-51-DE
• Date of registration: 08/04/2015
• Prospective Registration: Yes
• Primary sponsor: Chiasma, Inc.
• Public title: Follow-Up Study in Patients that Participated in the Chiasma Study CH-ACM-01
• Scientific title: Follow-Up Study in Patients with Acromegaly Previously Participating in Chiasma Study CH-ACM-01
• Date of first enrolment: 30/06/2015
• Target sample size: 98
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001292-51
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Follow up without the administration of study drug If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 0
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Medpace Regulatory Submissions
• Affiliation: Medpace, Inc.

• Name: Medpace Regulatory Submissions
• Affiliation: Medpace, Inc.

Key inclusion & exclusion 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 <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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

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

Intervention(s)

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)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: Not applicable

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.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Not Applicable

Secondary end point(s): Not Applicable

Secondary ID(s)

CH-ACM-01-FU

Source(s) of Monetary Support

Chiasma, Inc