Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects

NCT02807233 | Completed

• 2 other identifiers: A-ES-52030-352IPS-SOM-2015-01
• Study Type: observational
• Target: 115
• Locations: 2 countries
• Sites: 39

Brief Summary

The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (\>4 weeks) in subjects with acromegaly in daily clinical practice.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.

  Day 1

Secondary Outcomes (8)

• Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.

  Day 1

• Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks.

  Day 1

• Percentage of subjects whose dosing regimen has been changed in the six months before the study.

  Day 1

• Preference for self-administered injections or administration in an outpatient clinic by a medical professional.

  Day 1

• Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients

You may qualify if:

• Men or women aged ≥ 18 years
• Diagnosed with acromegaly
• Receiving treatment with ATG 120 mg at extended dosing intervals (\> 4 weeks) for at least six months before the study visit.
• Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.
• Able to sign the informed consent form for study participation.

You may not qualify if:

• Received radiation therapy treatment in the last six months.
• Active participation in another clinical study.
• Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.
• Pregnancy or breastfeeding for female patients.
• No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (39)

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Sao Jöao

Porto, 4200-319, Portugal

Location

Hospital Univ. Nuestra Sra. Candelaria

Santa Cruz, Tenerife, 38010, Spain

Location

Complejo Hospitalario Univ. A Coruña

A Coruña, 15006, Spain

Location

Hospital Univ. Príncipe de Asturias

Alcalá de Henares, 28805, Spain

Location

Hospital General Univ. de Alicante

Alicante, 03010, Spain

Location

Hospital Univ. La Ribera

Alzira, 46600, Spain

Location

Hospital Infanta Cristina

Badajoz, 06006, Spain

Location

Hospital Cruces

Barakaldo, 48903, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Hospital de Getafe

Getafe, 28905, Spain

Location

Hospital Univ. Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital de Jaén

Jaén, 23005, Spain

Location

Hospital Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Univ. León

León, 24001, Spain

Location

Hospital Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital La Princesa

Madrid, 28006, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Univv. La Paz

Madrid, 28046, Spain

Location

Hospital Puerta del Hierro

Madrid, 28222, Spain

Location

Hospital Civil de Málaga

Málaga, 29009, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Univ. Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Univ. Son Espases

Palma, 07120, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, 08208, Spain

Location

Hospital Infanta Sofía

San Sebastián de los Reyes, 28702, Spain

Location

Hospital Clínico Univ. Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Univ. Alava

Terrassa, 08221, Spain

Location

Hospital Univ. Mutua de Terrassa

Terrassa, 08221, Spain

Location

Hospital Obispo Polanco

Teruel, 44002, Spain

Location

Hospital Virgen de la Salud

Toledo, 45005, Spain

Location

Hospital Clínico de Valencia

Valencia, 46010, Spain

Location

Hospital Univ. La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Univ. Valladolid

Valladolid, 47003, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 21, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

ES (37); PT (2)