Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.

No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.

Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Benamouzig
• Treatments: Pasireotide; Somatostatin

Criteria

Inclusion Criteria:

1. Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy.

2. 6 or more of packed red cells unit transfusion during the 6 months prior inclusion.

3. Failed endoscopic therapy or cons-indication for endoscopic treatment.

4. Patient affiliated to a social security insurance.

5. Age > 18 years.

6. Consent signed by the patient.

Exclusion Criteria:

1. Treatment with somatostatin analogue in the 6 months prior to inclusion

2. Symptomatic cholelithiasis

3. Rendu-Osler disease

4. Uncontrolled diabetes (HbA1c > 8%)

5. Breaking of the esophageal varicose veins bleeding older than six months.

6. Patients treated with anti vitamin K at baseline and during the study.

7. Patients with (AST, ALT> 2 ULN) and / or total bilirubin > 1.5 ULN.

8. TP < 50%, platelets <75 000/mm3, aPTT> 1.5 times the control

9. Uncontrolled heart disease: myocardial infarction within 6 months, status epilepticus angina, congestive heart failure grade III and NYHA, ventricular tachycardia, ventricular fibrillation, heart block, severe

10. Family medical history of the idiopathic sudden death

11. Syncope like medical history

12. QTcF> 450 ms

13. Metastatic malignancy

14. Pregnant or nursing women, women of childbearing age who have not achieved pregnancy test, women and men of reproductive age without effective contraception

15. Impossible follow for psychological and/or geographical reasons.