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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003519
Recruitment Status : Withdrawn (Study timeline delay, low site feasibility and delay concerns due to COVID-19.)
First Posted : July 1, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

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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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA. [ Time Frame: baseline and 12 months ]
  8. Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA [ Time Frame: baseline and 12 months ]
  9. 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

  10. 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

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003519


Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04003519    
Other Study ID Numbers: A-DE-52030-368
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases