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A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Primary Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysisSecondary Objective: To characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (…

Pharmacogenetics of Mitotane

Primary objective:We hypothesize that genetic variability influences mitotane pharmacokinetics. Therefore our aim is to explore the inter-individual differences in genes coding for drug metabolizing enzymes in patients treated with mitotane and to…

Differentiated thyroid carcinoma in children: Late effects of treatment and pathophysiological background in the Netherlands

1) To study the late effects of 131-I treatment and TSH suppressive therapy as well as quality of life in patients with childhood-onset DTC. 2) To determine the presence of RET/PTC 1 and 3 translocations and BRAF mutations, and to investigate their…

Thyroid hormone analog therapy of patients with severe psychomotor retardation caused by mutations in the MCT8 thyroid hormone transporter: The Triac Trial.

1. Normalization of the abnormal serum TH parameters and thereby improving the clinical condition of the AHDS patients2. Observation of changes in cognitive and motor function.

A PROSPECTIVE, INTERNATIONAL, MULTI-CENTRIC, OPEN-LABEL STUDY TO ASSESS THE EFFICACY OF AN EXTENDED INJECTION INTERVAL SCHEDULE OF LANREOTIDE AUTOGEL 120 MG IN ACROMEGALIC SUBJECTS WHO ARE BIOCHEMICALLY CONTROLLED ON THE LONG TERM TREATMENT WITH OCTREOTIDE LAR 10 OR 20 MG

The purpose of this study is to look at the effect of changing from monthly (4 weekly) injections of your usual treatment (octreotide LAR) to less frequent treatment (once every 6 or 8 weeks) with lanreotide Autogel 120 mg injections. The study…

An open-label, multi-center, expanded access study of parireotide s.c. in patients with Cushing's disease (CSOM230B2406) (SEASCAPE)

Primary objective: Safety.Secondary objective: Efficacy.

Effect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration

Next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect of GH treatment on glucose metabolism, physical performance, and neuropsychological functioning of…

Adverse effects of radioiodine treatment on salivary glands in differentiated thyroid carcinoma patients

Primary Objectives 1. To assess whether radioiodine therapy results in hyposalivation, altered saliva composition and xerostomia in DTC patients.2. To assess whether the extent of radioiodine uptake on the pre- and post-therapy WBS and SPECT/CT is…

A Multicenter single-arm Extension Study to Describe the Long-term Safety
of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With
Chronic Kidney Disease on Hemodialysis.

Primary: characterize the long-term safety and tolerability of AMG 416 in the treatment of secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis.Secondary: to characterize intact parathyroid hormone (iPTH…

A single center two part study in healthy adult male subjects to determine the human mass balance and pharmacokinetics of a single oral dose of 14C-KHK75801 (Part 1) and to assess the absolute bioavailability based on the pharmacokinetic parameters of a single intravenous microdose of 14CKHK7580 following a single oral dose of KHK7580 (Part 2)

The purpose of Part 1 of the study is to investigate how quickly and to what extent KHK7580 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The compound to be administered will be…

Evaluation of Intraoperative and early postoperative Growth Hormone Levels for Transsphenoidal Resection in Acromegaly

Determination of prognostic value of intraoperative growth hormone levels on postoperative curation for acromegaly in patients undergoing transsphenoidal resection of pituitary adenoma.

A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing*s disease.

The primary endopoint is to determine whether ketoconazole/octreotide combination therapy, followed by octreotide monotherapy, is an effective treatment for Cushing's disease. Secundary endpoints address the effects of this therapy on bone…

A phase-I open label, balanced, randomized, crossover, two-groups, two-treatments, two-period, pilot study in healthy male subjects to determine the feasibility of a multiple dose dispenser for testosterone intranasal gel as measured by pharmacokinetics

The purpose of this study is to demonstrate the effectiveness of the multiple dose dispenser in comparison to the syringe as measured by a testsoterone pharmacokinetic profile

I-131 remnant ablation in differentiated thyroid cancer-optimal treatment with maximal outcome

To determine that rhTSH pretretament during euthyroidism ( already available in an number of centra in the Netherlands) in a adequately powered study is as good as the classical way of inducing hypothyrodism by withholding suppletion which induces…

Efficacy and safety of treatment with Cinacalcet in patients with Primary Hyperparathyroidism due to a MEN-1 mutation

1. What are the effects of cinacalcet on clinical and biochemical parameters, including bone turnover markers, in patients with primary hyperparathyroidism due to a MEN-I mutation?2. What are the effects of cinacalcet on bone mineral density and…

PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WITH MACROADENOMA.

To evaluate the efficacy of Lanreotide Autogel 120 mg when used as primary medical treatment in untreated de novo acromegalic patients with macroadenoma

A phase I open-label, balanced, randomized, crossover, three-groups, three-treatments, three-period, pharmacokinetic study of intranasal testosterone gel administration to healthy, adult, male subjects

The purpose of the study is to determine the PK profile of three different intranasal testosterone formulations.

A SINGLE ARM OPEN LABEL INTERNATIONAL MULTI CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT®) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS.

Evaluating the efficacy and safety of sunitinib in patients with progressive, advanced/metastatic well-differentiated, unresectable pancreatic neuroendocrine tumors.

An International, Randomised, Double-Blind, Two-Arm Study to Evaluate the Safety and Efficacy of Vandetanib 150 and 300 mg/day in Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma with Progressive or Symptomatic Disease.

The primary objective of this study is to assess the objective response rates (ORR) for two starting doses of vandetanib, 150 mg and 300 mg in patients with unresectable locally advanced or metastatic MTC having progressive or symptomatic disease.…

Pharmacokinetic modeling of mitotane

The main objective of this study is to construct a population-pharmacokinetic model, in order to evaluate the influence of patient characteristics on the pharmacokinetics of mitotane in patients treated with this oral therapy.