A Phase 2 interventional study of Recombinant human thyrotropin (Thyrogen) and recombinant human TSH in Nodular Goiter, sponsored by Steen Bonnema. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-04.
Sponsored by Steen Bonnema · Phase 2, Interventional, and Treatment
The study aims at clarifying (in a randomized, double-blinded design):
The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
19 studies on the registry are indexed under Goiter, Nodular; 6 are open to participants now.
This study's enrollment of 90 is above the median of 68 across 11 interventional studies indexed under Goiter, Nodular.
Browse Goiter, Nodular studies →Steen Bonnema is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
proceeded by 0.1 mg rhTSH
Drug: Recombinant human thyrotropin (Thyrogen) · Drug: recombinant human TSH
1 ml isotonic saline
Other: isotonic saline = placebo
0.1 mg rhTSH administered intramuscularly
0.1 mg rhTSH administered intramuscularly
0.1 mg isotonic saline injected intramuscularly
An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo
Time frame: 24 and 96 hours after tracer administration
An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH
Time frame: 24 and 96 hours after tracer administration
An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours)
Time frame: 24 and 96 hours after tracer administration
A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy
Time frame: 3, 6, 9 and 12 months after 131I therapy
A registration of adverse effects following rhTSH/placebo
Time frame: All adverse effects occuring within one year follow-up
Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).
Time frame: baseline, 3 and 12 months after 131I therapy
Development of TPOab or TSHRab
Time frame: At 12 months follow-up
Thyroid function
Time frame: At 12 months follow up.
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thyrotropin Alfa
Steen Bonnema