Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Ipsen

Status and phase: Withdrawn; Phase 2

Conditions: Acromegaly

Treatments: Drug: lanreotide (Autogel formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517491

A-38-52030-725

Details and patient eligibility

About

The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1.
• Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1.
• Patients must have serum GH level > 2.5 ng/mL AND serum IGF-1 level > 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg.

Exclusion criteria

• The patient has received pituitary radiation therapy of any kind at any time prior to visit 1.
• The patient has received pituitary surgery within 3 months prior to visit 1.
• The patient's serum creatinine is higher than 150 µmol/l.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

1

Experimental group

Treatment:

Drug: lanreotide (Autogel formulation)