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Trial record 1 of 1 for:    NCT00658879
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Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan

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ClinicalTrials.gov Identifier: NCT00658879
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Acromegaly
Intervention Drug: Somavert (Pegvisomant)
Enrollment 251
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Period Title: Overall Study
Started 251
Completed 250
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Baseline Participants 250
Hide Baseline Analysis Population Description
A total of 251 participants were enrolled in this study. Of the 251 participants, 1 participant was excluded from the baseline analysis due to protocol violation.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 250 participants
<15 years 2
≥15 and <65 years 198
≥65 years 50
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants
Female
141
  56.4%
Male
109
  43.6%
Hepatic Function Disorder  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 250 participants
Absent 234
Present 16
Renal Impairment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 250 participants
Absent 241
Present 9
Diabetes Mellitus (Concurrent Disease)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 250 participants
Absent 139
Present 111
1.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-related Adverse Event
89
  35.6%
Treatment-related Serious Adverse Event
20
   8.0%
2.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
9
   3.6%
3.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events by Gender
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
Female Number Analyzed 141 participants
52
  36.9%
Male Number Analyzed 109 participants
37
  33.9%
4.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events by Age
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
<15 years Number Analyzed 2 participants
2
 100.0%
≥15 and <65 years Number Analyzed 198 participants
75
  37.9%
≥65 years Number Analyzed 50 participants
12
  24.0%
5.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
Without hepatic function disorder Number Analyzed 234 participants
85
  36.3%
With hepatic function disorder Number Analyzed 16 participants
4
  25.0%
6.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
Without renal impairment Number Analyzed 241 participants
88
  36.5%
With renal impairment Number Analyzed 9 participants
1
  11.1%
7.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)
Hide Description A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
Without diabetes mellitus Number Analyzed 139 participants
57
  41.0%
With diabetes mellitus Number Analyzed 111 participants
32
  28.8%
8.Primary Outcome
Title Clinical Effectiveness Rate
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Percentage of Participants
96.4
9.Primary Outcome
Title Clinical Effectiveness Rate by Gender
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Percentage of Participants
Female Number Analyzed 126 participants
96.8
Male Number Analyzed 99 participants
96.0
10.Primary Outcome
Title Clinical Effectiveness Rate by Age
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Percentage of Participants
<15 years Number Analyzed 2 participants
50.0
≥15 and <65 years Number Analyzed 180 participants
96.1
≥65 years Number Analyzed 43 participants
100.0
11.Primary Outcome
Title Clinical Effectiveness Rate in Participants With Hepatic Function Disorder
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Percentage of Participants
Without hepatic function disorder Number Analyzed 212 participants
96.7
With hepatic function disorder Number Analyzed 13 participants
92.3
12.Primary Outcome
Title Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)
Hide Description Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description:
Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Percentage of Participants
Without diabetes mellitus Number Analyzed 126 participants
96.0
With diabetes mellitus Number Analyzed 99 participants
97.0
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
 
Arm/Group Title Somavert (Pegvisomant)
Hide Arm/Group Description Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion.
All-Cause Mortality
Somavert (Pegvisomant)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Somavert (Pegvisomant)
Affected / at Risk (%)
Total   39/250 (15.60%) 
Cardiac disorders   
Aortic valve incompetence * 1  1/250 (0.40%) 
Cardiac failure chronic * 1  1/250 (0.40%) 
Cardiac failure congestive * 1  2/250 (0.80%) 
Endocrine disorders   
Hypopituitarism * 1  1/250 (0.40%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/250 (0.80%) 
Diverticulum intestinal haemorrhagic * 1  1/250 (0.40%) 
Intestinal obstruction * 1  2/250 (0.80%) 
Large intestine polyp * 1  1/250 (0.40%) 
Nausea * 1  1/250 (0.40%) 
Volvulus * 1  1/250 (0.40%) 
General disorders   
Condition aggravated * 1  2/250 (0.80%) 
Disease progression * 1  11/250 (4.40%) 
Malaise * 1  1/250 (0.40%) 
Hepatobiliary disorders   
Drug-induced liver injury * 1  1/250 (0.40%) 
Hepatic function abnormal * 1  1/250 (0.40%) 
Liver disorder * 1  5/250 (2.00%) 
Immune system disorders   
Contrast media allergy * 1  1/250 (0.40%) 
Drug hypersensitivity * 1  1/250 (0.40%) 
Infections and infestations   
Appendicitis * 1  1/250 (0.40%) 
Cholecystitis infective * 1  1/250 (0.40%) 
Pyelonephritis * 1  1/250 (0.40%) 
Pyelonephritis acute * 1  1/250 (0.40%) 
Sepsis * 1  1/250 (0.40%) 
Injury, poisoning and procedural complications   
Compression fracture * 1  1/250 (0.40%) 
Fall * 1  1/250 (0.40%) 
Subdural haematoma * 1  1/250 (0.40%) 
Investigations   
Platelet count decreased * 1  1/250 (0.40%) 
White blood cell count decreased * 1  1/250 (0.40%) 
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/250 (0.40%) 
Hypercholesterolaemia * 1  1/250 (0.40%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  1/250 (0.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain neoplasm * 1  1/250 (0.40%) 
Colon cancer * 1  1/250 (0.40%) 
Hepatic cancer metastatic * 1  1/250 (0.40%) 
Lung neoplasm malignant * 1  1/250 (0.40%) 
Metastases to lung * 1  1/250 (0.40%) 
Neoplasm progression * 1  1/250 (0.40%) 
Neoplasm skin * 1  1/250 (0.40%) 
Pancreatic carcinoma * 1  1/250 (0.40%) 
Pituitary tumour * 1  8/250 (3.20%) 
Pituitary tumour benign * 1  4/250 (1.60%) 
Pituitary tumour recurrent * 1  3/250 (1.20%) 
Nervous system disorders   
Altered state of consciousness * 1  1/250 (0.40%) 
Epilepsy * 1  1/250 (0.40%) 
Hydrocephalus * 1  1/250 (0.40%) 
Loss of consciousness * 1  1/250 (0.40%) 
Seizure * 1  1/250 (0.40%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration * 1  1/250 (0.40%) 
Respiratory failure * 1  1/250 (0.40%) 
Surgical and medical procedures   
Cardiac resynchronisation therapy * 1  1/250 (0.40%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Somavert (Pegvisomant)
Affected / at Risk (%)
Total   195/250 (78.00%) 
Gastrointestinal disorders   
Nausea * 1  5/250 (2.00%) 
Abdominal pain * 1  4/250 (1.60%) 
Constipation * 1  4/250 (1.60%) 
Diarrhoea * 1  3/250 (1.20%) 
General disorders   
Disease progression * 1  15/250 (6.00%) 
Condition aggravated * 1  4/250 (1.60%) 
Injection site induration * 1  4/250 (1.60%) 
Malaise * 1  4/250 (1.60%) 
Injection site hypertrophy * 1  3/250 (1.20%) 
Injection site pruritus * 1  3/250 (1.20%) 
Hepatobiliary disorders   
Hepatic function abnormal * 1  34/250 (13.60%) 
Liver disorder * 1  10/250 (4.00%) 
Infections and infestations   
Nasopharyngitis * 1  3/250 (1.20%) 
Investigations   
Blood glucose increased * 1  6/250 (2.40%) 
Gamma-glutamyltransferase increased * 1  6/250 (2.40%) 
Weight increased * 1  5/250 (2.00%) 
Blood growth hormone increased * 1  4/250 (1.60%) 
Alanine aminotransferase increased * 1  3/250 (1.20%) 
Aspartate aminotransferase increased * 1  3/250 (1.20%) 
Glycosylated haemoglobin increased * 1  3/250 (1.20%) 
Metabolism and nutrition disorders   
Diabetes mellitus * 1  8/250 (3.20%) 
Hyperglycaemia * 1  5/250 (2.00%) 
Obesity * 1  7/250 (2.80%) 
Dyslipidaemia * 1  3/250 (1.20%) 
Hyperuricaemia * 1  3/250 (1.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pituitary tumour * 1  12/250 (4.80%) 
Pituitary tumour recurrent * 1  5/250 (2.00%) 
Pituitary tumour benign * 1  4/250 (1.60%) 
Nervous system disorders   
Headache * 1  9/250 (3.60%) 
Dizziness * 1  4/250 (1.60%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation * 1  3/250 (1.20%) 
Vascular disorders   
Hypertension * 1  6/250 (2.40%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658879    
Other Study ID Numbers: A6291023
First Submitted: April 9, 2008
First Posted: April 15, 2008
Results First Submitted: September 26, 2017
Results First Posted: January 22, 2019
Last Update Posted: January 22, 2019