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

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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Recruitment Status : Withdrawn (Study timeline delay, low site feasibility and delay concerns due to COVID-19.)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

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
 (submitted: June 28, 2019)
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
 (submitted: June 28, 2019)
  • 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 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.
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
 (submitted: June 1, 2020)
0
Original Estimated Enrollment
 (submitted: June 28, 2019)
81
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:

  • Participation in an interventional trial at the same time and/or within 3 months before baseline
  • Subject represented by a legal guardian
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT04003519
Other Study ID Numbers A-DE-52030-368
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date June 2020