CH-ACM-01 Follow Up Study
Research type
Research Study
Full title
Follow-Up Study in Patients with Acromegaly Previously Participating in Chiasma Study CH-ACM-01
IRAS ID
177903
Contact name
Marta Korbonits
Contact email
Sponsor organisation
Chiasma, Inc.
Eudract number
2015-000441-23
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
Acromegaly is a rare disease causing bone, tissue and organ growth due to the over production of growth hormones (GH) and insulin-like growth factors (IGF-1). The high levels of these hormones leads to a wide range of associated diseases affecting the heart and lungs, the levels of hormones released directly into the bloodstream and the metabolism. In many cases the reason for Acromegaly is due to a tumour on the pituitary gland, in the brain.
Many of the current treatments of Acromegaly involve the use of injectable medicines called Somatostatin analogs (SSTa). This follow study aims to assess the safety and the effectiveness of a new formulation of one of these treatments - octreotide. This new formulation will allow people who suffer from acromegaly to swallow their medication instead of injecting it, this cannot be done at present since the acids present in the stomach prevent enough medicine being absorbed to make it an effective treatment for Acromegaly. This has been accomplished by using an enteric coated capsule filled with an oily suspension of octreotide formulated with a chemical called a transient permeability enhancer (TPE) - this complex formulation allows the medicine to pass through the stomach to the small intestine where the capsule disintegrates and the medicine is then absorbed.
Based on results from 4 previous clinical trials where Octreolin has been given to 73 healthy female and male volunteers, Octreolin was safe and well-tolerated in all subjects. The side effects seen were similar to those for the Sandostatin (approved SSTa) control arms and to that reported for octreotide.therapy during the two-week follow-up period at the end of the
CH-ACM-01 study;
2. To assess documented disease control and rationale for
re-initiating parenteral treatment, during the follow-up period
of the CH-ACM-01 study, in responders to octreotide capsules
at the end of the treatment period (CH-ACM-01 Core +
Extension).REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0067
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion