美国头颈部、脑 Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly (PLAN-A)-出境医

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出境医 / 临床实验 / Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly (PLAN-A)

Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly (PLAN-A)

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Study Description

Brief Summary:

The purpose of the study is to collect data about predictive factors for the efficacy of Lanreotide Autogel in patients with acromegaly in routine clinical practice.

Condition or disease
Acromegaly

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	0 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Estimated Study Start Date :	April 2020
Estimated Primary Completion Date :	June 30, 2023
Estimated Study Completion Date :	December 30, 2023

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Proportion of subjects with normalization of centrally assessed age and sex adjusted IGF-I levels at visit 4 (about 12 months) after treatment start with lanreotide autogel. [ Time Frame: 12 months ]

Secondary Outcome Measures :

Proportion of subjects with normalization of centrally assessed age- and sex-adjusted IGF-I levels at visit 2, 3, and 5 after treatment start with lanreotide autogel [ Time Frame: 3 , 6 and 18 months ]
Changes from baseline of centrally assessed IGF-I levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel [ Time Frame: 3, 6, 12 and 18 months ]
Changes from baseline of centrally assessed random GH-levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel [ Time Frame: 3, 6, 12 and 18 months ]
Changes from baseline of centrally assessed GH-BP levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel [ Time Frame: 3, 6, 12 and 18 months ]
Proportion of subjects with GH-normalization - defined as centrally assessed random GH-levels (GH < 1 μg/L) - at visits 2, 3, 4, and 5 during treatment with lanreotide autogel. [ Time Frame: 3, 6, 12 and 18 months ]
Predictors for reduction of age- and sex-adjusted IGF-I to normal levels (control of acromegaly) at visits 4 compared to baseline and Last Visit Available (LVA) compared to baseline. [ Time Frame: baseline and 12 months ]
Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA. [ Time Frame: baseline and 12 months ]
Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA [ Time Frame: baseline and 12 months ]
Patient's global impression of change (PGIC) [ Time Frame: 3, 6, 12 and 18 months ]
Scale is used to assess the validity of Patient Global Impression of Change (PGIC). the score ranges between 1= very much worse and 7 = very much improved
Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC) [ Time Frame: Baseline, 3, 6, 12 and 18 months ]
It will be measured using Numerical Rating Scale to assess the average presence or severity of the symptoms. The score ranges from 0 = no symptom at all to 10 = maximum intensity of the symptom
Quality of life between baseline and visits 2, 3, 4 and 5. [ Time Frame: Baseline, 3, 6, 12 and 18 months ]
Measured by a generic, multipurpose short-form survey with 12 questions (SF-12). Scale provides information about mental and physical functioning and overall health-related-QoL. ". Higher scores indicate a better QoL.

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult subjects with biochemically active acromegaly, without previous treatment (medical treatment or radiotherapy) except for surgery and/or dopamine agonists (treatment terminated at or before baseline) who are already planned within the medical routine to be treated with lanreotide autogel.

Criteria

Inclusion Criteria:

Male or female aged 18 years and older with the capacity to consent
Signed written informed consent
Subject with hormonally active acromegaly defined by locally measured IGF-I levels 1.3 times above the age- and sex-adjusted normal range as determined at the last routine visit before baseline and after surgery
Subject with the intention to be treated with lanreotide autogel according to the current local SmPC (Germany, Austria) prior to study enrolment

Exclusion Criteria:

Participation in an interventional trial at the same time and/or within 3 months before baseline
Subject represented by a legal guardian

Contacts and Locations

Sponsors and Collaborators

Ipsen

Investigators

Layout table for investigator information

Study Director:	Ipsen Medical Director	Ipsen

Tracking Information

First Submitted Date

June 27, 2019

First Posted Date

July 1, 2019

Last Update Posted Date

June 2, 2020

Estimated Study Start Date

April 2020

Estimated Primary Completion Date

June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Proportion of subjects with normalization of centrally assessed age and sex adjusted IGF-I levels at visit 4 (about 12 months) after treatment start with lanreotide autogel. [ Time Frame: 12 months ]

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Proportion of subjects with normalization of centrally assessed age- and sex-adjusted IGF-I levels at visit 2, 3, and 5 after treatment start with lanreotide autogel [ Time Frame: 3 , 6 and 18 months ]
Changes from baseline of centrally assessed IGF-I levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel [ Time Frame: 3, 6, 12 and 18 months ]
Changes from baseline of centrally assessed random GH-levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel [ Time Frame: 3, 6, 12 and 18 months ]
Changes from baseline of centrally assessed GH-BP levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel [ Time Frame: 3, 6, 12 and 18 months ]
Proportion of subjects with GH-normalization - defined as centrally assessed random GH-levels (GH < 1 μg/L) - at visits 2, 3, 4, and 5 during treatment with lanreotide autogel. [ Time Frame: 3, 6, 12 and 18 months ]
Predictors for reduction of age- and sex-adjusted IGF-I to normal levels (control of acromegaly) at visits 4 compared to baseline and Last Visit Available (LVA) compared to baseline. [ Time Frame: baseline and 12 months ]
Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA. [ Time Frame: baseline and 12 months ]
Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA [ Time Frame: baseline and 12 months ]
Patient's global impression of change (PGIC) [ Time Frame: 3, 6, 12 and 18 months ]
Scale is used to assess the validity of Patient Global Impression of Change (PGIC). the score ranges between 1= very much worse and 7 = very much improved
Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC) [ Time Frame: Baseline, 3, 6, 12 and 18 months ]
It will be measured using Numerical Rating Scale to assess the average presence or severity of the symptoms. The score ranges from 0 = no symptom at all to 10 = maximum intensity of the symptom
Quality of life between baseline and visits 2, 3, 4 and 5. [ Time Frame: Baseline, 3, 6, 12 and 18 months ]
Measured by a generic, multipurpose short-form survey with 12 questions (SF-12). Scale provides information about mental and physical functioning and overall health-related-QoL. ". Higher scores indicate a better QoL.

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly

Official Title

Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly

Brief Summary

The purpose of the study is to collect data about predictive factors for the efficacy of Lanreotide Autogel in patients with acromegaly in routine clinical practice.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Condition

Acromegaly

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Withdrawn

Actual Enrollment

Original Estimated Enrollment

Estimated Study Completion Date

December 30, 2023

Estimated Primary Completion Date

June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 years and older with the capacity to consent
Signed written informed consent
Subject with hormonally active acromegaly defined by locally measured IGF-I levels 1.3 times above the age- and sex-adjusted normal range as determined at the last routine visit before baseline and after surgery
Subject with the intention to be treated with lanreotide autogel according to the current local SmPC (Germany, Austria) prior to study enrolment

Exclusion Criteria: