An interventional study of bioelectrical impedance analysis and blood draw in Ataxia Telangiectasia, sponsored by Johann Wolfgang Goethe University Hospital. Status unknown at 1 site in Germany. Open to participants aged 2 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Johann Wolfgang Goethe University Hospital · Not applicable, Interventional, and Diagnostic
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Among 11 studies in Ataxia Telangiectasia with a site in Germany — none open to participants now, 1 under way, 1 of them phase 3. Ataxia Telangiectasia · Germany.
Among the 11 studies in Ataxia Telangiectasia with a site in Germany, this one is the 7th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2016, is one of 2 with no phase, and was the 4th registered.
42 studies on the registry are indexed under Ataxia Telangiectasia; 7 are open to participants now.
Browse Ataxia Telangiectasia studies →None of the 11 studies in Ataxia Telangiectasia with a site in Germany is open now. The open studies under Ataxia Telangiectasia, anywhere →
Of the 5 Ataxia Telangiectasia studies recruiting now, 3 set no upper age limit and 2 stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 2 Years to 45 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is close to the median of 30 across 28 interventional studies indexed under Ataxia Telangiectasia.
Median enrollment 58 across the 10 interventional studies, 40 across the 1 observational. Of the 7 that completed or were terminated, 4 (57%) have results posted.
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6 of 11 have an industry lead sponsor. The 5 most frequent:
Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.
Johann Wolfgang Goethe University Hospital has 6 studies filed under Ataxia Telangiectasia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Ataxia Telangiectasia with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by progressive cerebellar ataxia, immunodeficiency, chromosomal instability and cancer susceptibility. The immunodeficiency is expressed by recurring infections. It's characterised by decreased lymphocytes data as well as lack of immunglobulin A, immunglobulin G subclasses and specific antibodies against pneumococcus. Aim of the present clinical trial is to investigate frequency-, intensity- and duration of the infections as well as changes oft immune status, dimension of liver disease and tumor risk in patients with A-T, with and without immunoglobulin G substitution therapy. Transient elastography (FibroScan) will be performed in order to measure liver stiffness as an indication of fatty liver and liver fibrosis. A bioelectrical impedance analysis (BIA) is conducted to investigate the exact body composition. Ataxia Score is determined to define neurological problems. Every subject receives a diary to compile symptoms of infection.
Ataxia teleangiectasia (A-T) is a rare devastating human recessive disorder characterized by progressive cerebellar ataxia, immunodeficiency, chromosomal instability and cancer susceptibility. The immunodeficiency is expressed by recurring infections. It's characterised by decreased lymphocytes data as well as lack of immunglobulin A, immunglobulin G subclasses and specific antibodies against pneumococcus as shown in many trials. Additionally the patients suffer from a fatty liver with increased transaminases and have the risk for a cirrhosis of the liver and a hepatocellular carcinoma. It's known that the dimension of the liver disease affects susceptibility to infection. Nevertheless there are only a few studies treating this problem.
Despite the proof of the immunodeficiency polyvalent immunoglobulins (IgG) are not given regularly. Own observations show that in spite of the treatment with immunoglobulins the progression of a chronic destructive lung disease with development of bronchiectasis hardly can prohibited.
Up to now it isn't cleared if a substitution therapy with immunoglobulins reduces the susceptibility to infection. Therefore the aim oft the present clinical trial ist to explore frequency-, intensity, and duration oft the infections as well as changes oft the immune status, measure of liver disease and tumor risk in patients with A-T, with and without immunoglobulin therapy. The study includes five visits, which are performed in all A-T patients. Visit 1, 3, 5 are realized in the context of annual follow ups:
Visit 2 and 4 are additionally conducted as study visits:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A-T patients aged 2 to 45 years with and without immunoglobulin G Substitution * bioelectrical impedance Analysis * blood draw * transient elastography (FibroScan) * ataxia score * Five-Times-Sit-to-Stand Test
Diagnostic Test: bioelectrical impedance analysis · Diagnostic Test: blood draw · Diagnostic Test: transient elastography (FibroScan) · Diagnostic Test: ataxia score · Diagnostic Test: Five-Times-Sit-to-Stand Test
Electrophysical measurement that allows to determine the exact composition of single body compartments by producing a magnetic field and detecting the potential difference through the body
Blood samples are taken from sober patients
FibroScan is a noninvasive tool to measure liver stiffness as an indication of fatty liver and liver fibrosis using ultrasound
Klockgether ataxia score ranges from 0 to 35 points in which 0 means no symptoms and 35 stands for final stage of disease. It includes seven ataxia associated symptoms: dysarthria, intention tremor, ataxia of gait, stance, dysdiadochokinesia, upper limb and lower limb
The test measures the complete time which is necessary for an individual to stand up and sit down on a chair five times in series
Infections in A-T
Evaluation of frequency, severity and intensity of infections in A-T patients with and without immunoglobulin G substitution
Time frame: 24 months
Liver disease
Evaluation of the degree of liver disease measured by liver enzymes and structural changes by transient elastography (Fibroscan) in A-T patients
Time frame: 24 months
Cancer risk
Evaluation of tumor markers in A-T patients
Time frame: 24 months
Plan to share: Undecided
Started Oct 2016 (actual). Primary completion is estimated for Sep 2018, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Johann Wolfgang Goethe University Hospital →