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Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone

NCT00383708•Ipsen

View on ClinicalTrials.gov

Summary

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels
•The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the last injection
•At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir \> 1 µg/L (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg

Exclusion Criteria

•The patient has undergone pituitary surgery or radiotherapy within 6 months prior to study entry, or it is anticipated that it will be done during the study
•The patient has already been treated with a somatostatin analogue associated with a GH antagonist
•The patient has received dopamine agonist within 6 weeks prior to the study entry
•The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)
•The patient is at risk of pregnancy or is lactating

Locations (24)

University Hospital, Charles University

Hradec Králové, Czechia

Charles University

Prague, Czechia

Aarhus Kommunehospital

Aarhus, Denmark

Groupe Hospitalier Henri Mondor- Albert Chenevier

Créteil, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Clinique Marc Linquette

Lille, France

Hôpital de la Timone

Marseille, France

CHU de Rangueil

Toulouse, France

Charite Campus Mitte

Berlin, Germany

Klinikum Johann Wolfgang Goethe-Universität

Frankfurt, Germany

Key Dates

Start Date

October 1, 2006

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

September 27, 2022

Enrollment

125

ACTUAL participants

Conditions

Acromegaly

Interventions

lanreotide (Autogel formulation)

DRUG

Pegvisomant

DRUG

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

NCT00001595

PanhypopituitarismGigantism/Acromegaly+2 more

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ACTIVE_NOT_RECRUITINGPHASE3

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

NCT04837040

Acromegaly

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

Inclusion Criteria

Exclusion Criteria

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy

Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China