Non Interventional Study For Patients Treated With Somavert®

Study Overview
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Brief Summary
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This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.

Detailed Description
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Non probability samples

Official Title
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German Non Interventional Study For Patients Treated With Somavert®

Conditions
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Acromegaly

Intervention / Treatment
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* Other: Non Interventional Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study. Exclusion Criteria: Subjects treated with an investigational drug for treatment of acromegaly. Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery. Women who were pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Other: Non Interventional Observation<br>* Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events (SAE) and Adverse Events (AE) | Long term safety of Somavert in treatment of patients with acromegaly | Baseline up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Insulin-like Growth Factor I (IGF-I) | Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay). | Baseline, Follow-up 1 (FUP 1) at  6 months , Follow-up 2 (FUP 2) at  12 months, Follow-up 3 (FUP 3) at   24 months, Follow-up 4 (FUP 4) at   36 months, Follow-up 5 (FUP 5) at   48 months, Follow-up 6 (FUP 6)at  60 months | 
| IGF-I Values Within Normal Range | Number of participants who have IGF-I values within normal range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| IGF-I Values Above Normal Range | Number of participants who have IGF-I values above normal range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Change From Baseline Hemoglobin A 1c (HbA 1c) | Change: HbA 1c at observation minus HbA 1c at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| HbA 1c Values Within Normal Range | Number of participants who have HbA 1c values within normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| HbA 1c Values Below Normal Range | Number of participants who have HbA 1c values below normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6) | 
| HbA 1c Values Above Normal Range | Number of participants with HbA 1c values above normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Change From Baseline Glucose (Fasting) | Change: glucose at observation minus glucose at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3) | 
| Glucose Values Within Normal Range (Fasting) | Number of participants who have glucose values within normal range (fasting). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose Values Below Normal Range (Fasting) | Number of participants with glucose values below normal range (fasting). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose Values Above Normal Range (Fasting) | Number of participants with glucose values above normal range (fasting). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Number of participants with glucose values (2h oGTT) within normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Number of participants with glucose values (2h oGTT) above normal range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| IGF-I Absolute Values | IGF-I absolute values (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Absolute Glucose Values (Fasting) | Absolute Glucose values (fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Absolute Glucose Values (2h oGTT) | Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Absolute Hemoglobin A 1c (HbA 1c) Values | Absolute value Hemoglobin A 1c (HbA 1c) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Change: HbA 1c at observation minus HbA 1c at baseline. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| HbA 1c Values Within Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Within Normal Range. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| HbA 1c Values Below Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Below Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| HbA 1c Values Above Normal Range in Diabetic Patients | Number of Diabetic Patients with HbA 1c Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose Change From Baseline in Diabetic Patients (Fasting) | Change: glucose at observation minus glucose at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Absolute Glucose Values in Diabetic Patients (Fasting) | Absolute Glucose Values in Patients with Diabetes (fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible). | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | 
| Mean Change From Baseline for Body Weight | Change: body weight at observation minus body weight at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | 
| Change From Baseline for Diastolic Blood Pressure (BP) | Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | 
| Change From Baseline for Systolic Blood Pressure (BP) | Change: systolic blood pressure at observation minus systolic blood pressure at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | 
| Change From Baseline in Ring Size | Change from baseline: ring size at observation minus ring size at baseline | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 
| Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study