Graves Disease (Basedow's Disease)Phase 3NCT01295333
Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance
A Phase 3 study testing the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation and The initiation of LT4 as soon as the first biological signs of hypothyroidism. in people with Graves Disease (Basedow's Disease), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease (Basedow's Disease)
- What is being tested?
- the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation and The initiation of LT4 as soon as the first biological signs of hypothyroidism.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131.
- Patient without or with ophtalmopathie junior defined by a score of ophtalmopathie in 0 or in 1 and a score of clinical activity in 0 (see secondary).
- Patient whose rate of fT4 and\or of fT3 is lower than 1,5 times the superior limit of the standards of the laboratory during the balance sheet(assessment) which precedes the treatment by iodine 131 (15j.
- Patient whose thyroïdien volume estimated by echography is lower than 60 mL.
- Patient whose treatment by anti-thyroïdiens of synthesis was interrupted at least 5 days before the administration of iodine 131.
- 18 years old male or feminine Patient or more.
Who cannot join
- Patient presenting a thyroïdien nodule suspect of wickedness.
- Patient presenting disorders not thyroïdiens known to distort the fixation of I131 (congestive heart failure of class III or IV, renal insufficiency).
- Patient having received by intravenous way a product of hydrosoluble contrast for radiography in 4 weeks preceding the randomization, or by way intra-thécale or for cholécystographie by a product of contrast iodized in three months preceding the randomization.
- Patient taking medicines susceptible to disrupt the function thyroïdienne or renal (renal medicines, lithium, amiodarone, in particular).
- Patient presenting a contraindication to Levothyroxine with high dose: décompensée heart disorder, coronaropathie, shady of the unchecked rhythm.
- pregnant or breast-feeding Women, or patient being able to have children and refusing to follow a reliable contraceptive method during the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
- Conditions
- Graves Disease (Basedow's Disease)
- Being tested
- the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation, The initiation of LT4 as soon as the first biological signs of hypothyroidism.
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablationDrug
The initiation of LT4 as soon as the first biological signs of hypothyroidism.Drug
| Study group | Role | What they receive |
|---|---|---|
| conventional approach | Other | conventional traitment Receives: Drug: The initiation of LT4 as soon as the first biological signs of hypothyroidism. |
| experimental approach | Experimental | early and systematic traitment Receives: Drug: the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO).
Measured: 2 years
Secondary outcomes (1)
compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves Disease (Basedow's Disease)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295333
- Sponsor's protocol ID
- 2010-023608-28
- Other IDs
- 2010-23
- Status last verified
- Apr 2015
- First submitted
- 27 Jan 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance
- ClinicalTrials.gov ID
- NCT01295333
- Acronym / sponsor ID
- 2010-023608-28
- Conditions
- Graves Disease (Basedow's Disease)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional approach | Other | Drug: The initiation of LT4 as soon as the first biological signs of hypothyroidism.conventional traitment |
| experimental approach | Experimental | Drug: the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablationearly and systematic traitment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131.
Key exclusion criteria (6 listed)
- Patient presenting a thyroïdien nodule suspect of wickedness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation | Drug | experimental approach |
| The initiation of LT4 as soon as the first biological signs of hypothyroidism. | Drug | conventional approach |
Primary outcome
will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO).
Time frame: 2 years
1 secondary outcome
compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation and The initiation of LT4 as soon as the first biological signs of hypothyroidism. in people with Graves Disease (Basedow's Disease), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.