search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Het effect van pegvisomant op kwaliteit van leven en insuline gevoeligheid. The effect of pegvisomant on quality of life and insulin sensitivity


- candidate number15226
- NTR NumberNTR4103
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2013
- Secondary IDsNL37992 078 11 
- Public TitleHet effect van pegvisomant op kwaliteit van leven en insuline gevoeligheid. The effect of pegvisomant on quality of life and insulin sensitivity
- Scientific TitleRandomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF-I levels has been normalized by long-acting somatostatin analogues
- ACRONYMPEQoL
- hypothesisNormal IGF1 levels during somatostatin analogue treatment will not normalize Growth hormone (GH) levels at the tisuue levels. By adding Pegviomant (GH antagonist) we will block this GH effect and improve the typical residual complaints of the patients and improve the Quality of life.
- Healt Condition(s) or Problem(s) studiedAcromegalia, Pituitary tumor, IGF1
- Inclusion criteriaA written informed consent. Male or female age ≥ 18 years. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF1 levels. The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF1 level above the 60th percentile and below 1.2 x ULN, 28 days after the last injection.
- Exclusion criteriaHas undergone pituitary surgery or radiotherapy within 6 months prior to study entry. If patients have an optimal QoL (100%) assessed by the AcroQoL physical dimension, they cannot enter the study. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure. Has already been treated with a somatostatin analogue associated with pegvisomant. Has received a dopamine agonist within 6 weeks prior to study entry. Has been treated with any unlicensed drug within the last 30 days before study entry. Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 2 ULN). Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study. Has a history of, or known current, problems with alcohol or drug abuse. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subjectís safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. Renal insufficiency, clearance < 60 ml/min
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2013
- planned closingdate31-dec-2014
- Target number of participants40
- InterventionsStudy Product:
Pegvisomant or placebo will be administered via subcutaneous injections once weekly. Both are powders and need to be solved in sterile water. The vials are equal for the placebo and Pegvisomant, as well are the water vials
- Primary outcomePrimary Efficacy Variables:
Change in the Quality of Life over 16 weeks. Assessed by AcroQoL and PASQ.
- Secondary outcomeSafety Variables:
Adverse event and local tolerance information recorded at any time throughout the study.
Vital signs recorded at visits V1, V2, V3, V4, V5 & V6.
Physical examination recorded at visits V1, V2, V4 & V6.
Cardiac- sonography and glucose tolerance based on oral glucose tolerance test measured at visits V1 and V6. HbA1C will be measure at visits V1, V2, V3, V4, V5 & V6. Laboratory tests: QoL, standard hematology and biochemistry plus, IGF-I levels, GH levels, PEG-levels, ALT, AST, GGT, AP, PT and total bilirubin will be measured at visits V1, V2, V4, V5 and V6.
Pituitary MRI prior and at the end of the study.
Pharmacokinetic Variables:
Pegvisomant serum levels will be assessed in all patients at visits V2, V4, V6.
- TimepointsScreening visit (V1):
Singed informed consent
QoL assessment
vital signs
physical examination
BIA
ECG
standard haematology
biochemistry plus, ALT, AST, GGT, AP, PT, total bilirubin
IGF1
GH
fasting glucose
HBA1C
BNP
Pregnancy test is applicable
OGTT and cardiac sonography will be preformed if patients are eligible between V1 and V2
Apotheek zorg will be notified to visit patient. Physician will check if patient had contact with Apotheek zorg within 2 weeks after notification.

Visit 2 (V2):
vital signs
physical examination
BIA
ECG
standard haematology
biochemistry plus, ALT, AST, GGT, AP, PT, total bilirubin
IGF1
GH
fasting glucose
HBA1C
BNP
QoL assessment

Visit 3 (V3) & Visit 5 (V5)
vital signs
BIA
ECG
standard haematology
biochemistry plus, ALT, AST, GGT, AP, PT, total bilirubin
IGF1
GH
fasting glucose
HBA1C
BNP
Pegvisomant levels
QoL assessment
Empty vials collection

Visit 4 (V4)
vital signs
physical examination
BIA
ECG
standard haematology
biochemistry plus, ALT, AST, GGT, AP, PT, total bilirubin
IGF1
GH
fasting glucose
HBA1C
BNP
QoL assessment
Pegvisomant levels
Empty vials collection

End of study visit or visit 6 (V6)
vital signs
physical examination
BIA
ECG
standard haematology
biochemistry plus, ALT, AST, GGT, AP, PT, total bilirubin
IGF1
GH
fasting glucose
HBA1C
BNP
QoL assessment
Pegvisomant levels
Empty vials collection
OGTT and cardiac sonography will be preformed if patients are eligible between week 15 and 17.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. S.J.C.M.M. Neggers
- CONTACT for SCIENTIFIC QUERIESMD. PhD. S.J.C.M.M. Neggers
- Sponsor/Initiator Erasmus University Medical Centre, Department of Medicine, Leiden University Medical Center (LUMC), Department Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Pfizer
- PublicationsN/A
- Brief summaryPrimary Study Objective:
To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the Quality of Life over 16 weeks in 60 acromegalic patients. The primary endpoint will be the change in the AcroQol-physical score at the end of the treatment period.
Secondary Study Objectives:
To assess the effect of low-dose pegvisomant co-administration on:
Total body water / body weight.
Blood pressure
HbA1c
BNP levels
Ring-size
IGF-I levels
Safety based on:
Adverse events, clinical examination, vital signs
Glucose tolerance
Standard hematology and biochemistry, including liver function tests

This will be a multicentre, randomized double blind study.
Patients eligible for the study will continue their usual dose and frequency of administration of a long-acting somatostatin analog. They will start using low-dose pegvisomant as add-on, or placebo as add-on. The dose of pegvisomant will be fixed. Acromegalic patients will be recruited in order to ensure 60 evaluable patients will enter the co-treatment period. All subjects should previously be treated with somatostatin analogues during which treatments their IGF-I levels should have normalized.
Inclusion criteria:
All patients must fulfill the following:
At the screening visit,
Provision of written informed consent prior to any study related procedures.
Male or female age ≥ 18 years.
The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-1 levels.
The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF-1 level above the 60th percentile and below ULN, 28 days after the last injection.
Exclusion Criteria
Patients will not be included in the study if he/she:
Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
If patients have an optimal QoL (100%) assessed by the AcroQoL physical dimension, they cannot enter the study. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study.
Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure. Has already been treated with a somatostatin analogue associated with pegvisomant.
Has received a dopamine agonist within 6 weeks prior to study entry.
Has been treated with any unlicensed drug within the last 30 days before study entry. Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 2 ULN).
Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study.
Has a history of, or known current, problems with alcohol or drug abuse.
Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subjectís safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Renal insufficiency, clearance < 60 ml/min. Participation in a clinical trail in the last 12 months.
Study Product:
Pegvisomant or placebo will be administered via subcutaneous injections once weekly. Both are powders and need to be solved in sterile water. The vials are equal for the placebo and Pegvisomant, as well are the water vials
- Main changes (audit trail)
- RECORD2-aug-2013 - 26-aug-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl